DE102004046244A1 - Expandable balloon mounted on stent, useful for the prevention or reduction of restenosis, comprises a coating of at least antiproliferative, antiinflammatory and/or antimycotic active substance on both stent and balloon - Google Patents

Expandable balloon mounted on stent, useful for the prevention or reduction of restenosis, comprises a coating of at least antiproliferative, antiinflammatory and/or antimycotic active substance on both stent and balloon Download PDF

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DE102004046244A1
DE102004046244A1 DE200410046244 DE102004046244A DE102004046244A1 DE 102004046244 A1 DE102004046244 A1 DE 102004046244A1 DE 200410046244 DE200410046244 DE 200410046244 DE 102004046244 A DE102004046244 A DE 102004046244A DE 102004046244 A1 DE102004046244 A1 DE 102004046244A1
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acid
stent
poly
antiproliferative
balloon
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Michael Orlowski
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Abstract

Expandable balloon (I) mounted on stent comprises a coating of at least antiproliferative, antiinflammatory and/or antimycotic active substance on both stent and balloon. Independent claims are also included for: (1) coating of (I) with mounted stent with at least a antiproliferative, antiinflammatory and/or antimycotic active substance comprising providing a balloon for a dilatations catheter, mounting an non-expanded stent, simultaneous coating of balloon and stent with at least an antiproliferative, antiinflammatory and/or antimycotic active agent; and (2) coated expandable balloon with mounted stent with at least antiproliferative, antiinflammatory and/or antimycotic active substance obtained by the method. ACTIVITY : Vasotropic. MECHANISM OF ACTION : None given.

Description

Die vorliegende Erfindung betrifft ein Coronarstentsystem umfassend einen Stent und einen Ballon geeignet für einen Dilatationskatheter, welches mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichtet ist.The The present invention relates to a coronary stent system comprising a stent and a balloon suitable for a dilatation catheter, which with at least one antiproliferative, anti-inflammatory and / or antifungal agent is coated.

Die Implantation von Stents ist heutzutage ein gängiger chirurgischer Eingriff zur Behandlung von Stenosen. Dabei ist noch immer eine sehr häufige Komplikation die sogenannte Restenose, d.h. der Wiederverschluss des Gefäßes. Eine genaue begriffliche Beschreibung der Restenose ist in der Fachliteratur nicht aufzufinden. Die am häufigsten verwendete morphologische Definition der Restenose ist diejenige, die nach erfolgreicher PTA (perkutane transluminale Angioplastie) die Restenose als eine Reduktion des Gefäßdurchmessers auf weniger als 50% des normalen festlegt. Hierbei handelt es sich um einen empirisch festgelegten Wert, dessen hämodynamische Bedeutung und Beziehung zur klinischen Symptomatik einer soliden wissenschaftlichen Basis entbehrt. In der Praxis wird häufig die klinische Verschlechterung eines Patienten als Zeichen einer Restenose des vormals behandelten Gefäßabschnitts angesehen.The Implantation of stents is now a common surgical procedure for the treatment of stenoses. It is still a very common complication the so-called restenosis, i. the reclosure of the vessel. A exact conceptual description of restenosis is in the literature not to be found. The most common used morphological definition of restenosis is the one after successful PTA (percutaneous transluminal angioplasty) restenosis as a reduction of vessel diameter to less than 50% of normal sets. This is an empirical one fixed value, its hemodynamic Significance and relationship to the clinical symptoms of a solid scientific basis is lacking. In practice, the clinical deterioration of a patient as a sign of restenosis of the previously treated vessel section considered.

Die Restenose nach einer Stentimplantation ist eine der Hauptursachen für einen erneuten Krankenhausaufenthalt. Die während der Implantation des Stents verursachten Gefäßverletzungen rufen Entzündungsreaktionen hervor, die für den Heilungsprozeß in den ersten sieben Tagen eine entscheidende Rolle spielen. Die hierbei ablaufenden Prozesse sind unter anderem mit der Ausschüttung von Wachstumsfaktoren verbunden, womit eine verstärkte Proliferation der glatten Muskelzellen eingeleitet wird und damit schon kurzfristig zu einer Restenose, einem erneuten Verschluß des Gefäßes aufgrund unkontrollierten Wachstums führen.The Restenosis after a stent implantation is one of the main causes for one Hospitalization again. The during implantation of the Stents caused vascular injuries call inflammatory reactions that's for the healing process in play a crucial role in the first seven days. The hereby ongoing processes include the distribution of growth factors connected, bringing a reinforced Proliferation of smooth muscle cells is initiated and thus already in the short term to a restenosis, a re-occlusion of the vessel due lead to uncontrolled growth.

Der vorliegenden Erfindung liegt die Beobachtung zugrunde, dass Ausmaß und Auftreten einer Restenose insbesondere durch die erste Woche nach der Stentimplantation bestimmt werden und es daher von besonderer Wichtigkeit ist, Entzündungen während dieser ca. ersten 7 Tage nach erfolgter Stentimplantation möglichst gut zu behandeln.Of the The present invention is based on the observation that extent and occurrence restenosis, especially during the first week after stent placement and it is therefore of particular importance to have inflammation during this period Approximately first 7 days after stent implantation if possible to treat well.

Aufgabe der vorliegenden Erfindung ist es, die Versorgung des den Stent umgebenden Gewebes mit einer ausrechenden Menge eines antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoffs insbesondere während der ersten Woche nach Stentimplantation sicher zu stellen.task The object of the present invention is to supply the stent surrounding tissue with an adequate amount of an antiproliferative, anti-inflammatory and / or antifungal agent in particular while the first week after stent implantation.

Die Aufgabe wird durch die technische Lehre der Patentansprüche 1, 7, 9 und 10 gelöst. Weitere vorteilhafte Ausgestaltungen der Erfindung ergeben sich aus den abhängigen Ansprüchen, der Beschreibung und den Beispielen.The The object is achieved by the technical teaching of claims 1, 7, 9 and 10 solved. Further advantageous embodiments of the invention will become apparent from the dependent ones claims, the description and the examples.

Die vorliegende Erfindung offenbart einen expandierbaren Ballon eines Dilatationskatheters mit einem aufgesetzten Stent, wobei Ballon und Stent mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichtet sind.The The present invention discloses an expandable balloon of a Dilatation catheter with an attached stent, being balloon and stent with at least one antiproliferative, anti-inflammatory and / or antifungal agent are coated.

Als antiproliferative, antiinflammatorische und/oder antimykotische Wirkstoffe können beispielsweise die aus der folgenden Liste gewählt werden:
Abciximab, Acemetacin, Acetylvismion B, Aclarubicin, Ademetionin, Adriamycin, Aescin, Afromoson, Akagerin, Aldesleukin, Amidoron, Aminoglutethemid, Amsacrin, Anakinra, Anastrozol, Anemonin, Anopterin, Antimykotika, Antithrombotika, Apocymarin, Argatroban, Aristolactam-All, Aristolochsäure, Ascomycin, Asparaginase, Aspirin, Atorvastatin, Auranofin, Azathioprin, Azithromycin, Baccatin, Bafilomycin, Basiliximab, Bendamustin, Benzocain, Berberin, Betulin, Betulinsäure, Bilobol, Bisparthenolidin, Bleomycin, Bombrestatin, Boswellinsäuren und ihre Derivate, Bruceanole A,B und C, Bryophyllin A, Busulfan, Antithrombin, Bivalirudin, Cadherine, Camptothecin, Capecitabin, o-Carbamoylphenoxyessigsäure, Carboplatin, Carmustin, Celecoxib, Cepharantin, Cerivastatin, CETP-Inhibitoren, Chlorambucil, Chloroquinphosphat, Cictoxin, Ciprofloxacin, Cisplatin, Cladribin, Clarithromycin, Colchicin, Concanamycin, Coumadin, C-Type Natriuretic Peptide (CNP), Cudraisoflavon A, Curcumin, Cyclophosphamid, Cyclosporin A, Cytarabin, Dacarbazin, Daclizumab, Dactinomycin, Dapson, Daunorubicin, Diclofenac, 1,11-Dimethoxycanthin-6-on, Docetaxel, Doxorubicin, Dunaimycin, Epirubicin, Epothilone A und B, Erythromycin, Estramustin, Etobosid, Everolimus, Filgrastim, Fluroblastin, Fluvastatin, Fludarabin, Fludarabin-5'-dihydrogenphosphat, Fluorouracil, Folimycin, Fosfestrol, Gemcitabin, Ghalakinosid, Ginkgol, Ginkgolsäure, Glykosid 1a, 4-Hydroxyoxycyclophosphamid, Idarubicin, Ifosfamid, Josamycin, Lapachol, Lomustin, Lovastatin, Melphalan, Midecamycin, Mitoxantron, Nimustin, Pitavastatin, Pravastatin, Procarbazin, Mitomycin, Methotrexat, Mercaptopurin, Thioguanin, Oxaliplatin, Irinotecan, Topotecan, Hydroxycarbamid, Miltefosin, Pentostatin, Pegasparase, Exemestan, Letrozol, Formestan, SMC-Proliferation-Inhibitor-2w, Mitoxanthrone, Mycophenolatmofetil, c-myc-Antisense, β-myc-Antisense, β-Lapachon, Podophyllotoxin, Podophyllsäure-2-ethylhydrazid, Molgramostim (rhuGM-CSF), Peginterferon α-2b, Lanograstim (r-HuG-CSF), Macrogol, Selectin (Cytokinantagonist), Cytokininhibitoren, COX-2-Inhibitor, NFkB, Angiopeptin, monoklonale Antikörper, die die Muskelzellproliferation hemmen, bFGF-Antagonisten, Probucol, Prostaglandine, 1-Hydroxy-11-Methoxycanthin-6-on, Scopolectin, NO-Donoren wie Pentaerythrityltetranitrat und Syndnoeimine, S-Nitrosoderivate, Tamoxifen, Staurosporin, β-Estradiol, α-Estradiol, Estriol, Estron, Ethinylestradiol, Medroxyprogesteron, Estradiolcypionate, Estradiolbenzoate, Tranilast, Kamebakaurin und andere Terpenoide, die in der Krebstherapie eingesetzt werden, Verapamil, Tyrosin-Kinase-Inhibitoren (Tyrphostine), Paclitaxel und dessen Derivate wie 6-α-Hydroxy-Paclitaxel, Taxotere, Kohlensuboxids (MCS) und dessen macrocyclische Oligomere, Mofebutazon, Lonazolac, Lidocain, Ketoprofen, Mefenaminsäure, Piroxicam, Meloxicam, Penicillamin, Hydroxychloroquin, Natriumaurothiomalat, Oxaceprol, β-Sitosterin, Myrtecain, Polidocanol, Nonivamid, Levomenthol, Ellipticin, D-24851 (Calbiochem), Colcemid, Cytochalasin A-E, Indanocine, Nocadazole, S 100 Protein, Bacitracin, Vitronectin-Rezeptor Antagonisten, Azelastin, Guanidylcyclase-Stimulator Gewebsinhibitor der Metallproteinase-1 und 2, freie Nukleinsäuren, Nukleinsäuren in Virenüberträger inkorporiert, DNA- und RNA-Fragmente, Plaminogen-Aktivator Inhibitor-1, Plasminogen-Aktivator Inhibitor-2, Antisense Oligonucleotide, VEGF-Inhibitoren, IGF-1, Wirkstoffe aus der Gruppe der Antibiotika wie Cefadroxil, Cefazolin, Cefaclor, Cefotixin Tobramycin, Gentamycin, Penicilline wie Dicloxacillin, Oxacillin, Sulfonamide, Metronidazol, Enoxoparin, desulfatiertes und N-reacetyliertes Heparin (Hemoparin®), Gewebe-Plasminogen-Aktivator, GpIIb/IIIa-Plättchenmembranrezeptor, Faktor Xa-Inhibitor Antikörper, Heparin, Hirudin, r-Hirudin, PPACK, Protamin, Prourokinase, Streptokinase, Warfarin, Urokinase, Vasodilatoren wie Dipyramidol, Trapidil, Nitroprusside, PDGF-Antagonisten wie Triazolopyrimidin und Seramin, ACE-Inhibitoren wie Captopril, Cilazapril, Lisinopril, Enalapril, Losartan, Thioproteaseinhibitoren, Prostacyclin, Vapiprost, Interferon α, β und γ, Histaminantagonisten, Serotoninblocker, Apoptoseinhibitoren, Apoptoseregulatoren wie p65, NF-kB oder Bcl-xL-Antisense-Oligonukleotiden, Halofuginon, Nifedipin, Tocopherol Tranilast, Molsidomin, Teepolyphenole, Epicatechingallat, Epigallocatechingallat, Leflunomid, Etanercept, Sulfasalazin, Etoposid, Dicloxacyllin, Tetracyclin, Triamcinolon, Mutamycin, Procainimid, Retinolsäure, Quinidin, Disopyrimid, Flecainid, Propafenon, Sotolol, natürliche und synthetisch hergestellte Steroide wie Inotodiol, Maquirosid A, Ghalakinosid, Mansonin, Streblosid, Hydrocortison, Betamethason, Dexamethason, nichtsteroidale Substanzen (NSAIDS) wie Fenoporfen, Ibuprofen, Indomethacin, Naproxen, Phenylbutazon und andere antivirale Agentien wie Acyclovir, Ganciclovir und Zidovudin, Clotrimazol, Flucytosin, Griseofulvin, Ketoconazol, Miconazol, Nystatin, Terbinafin, antiprozoale Agentien wie Chloroquin, Mefloquin, Quinin, des weiteren natürliche Terpenoide wie Hippocaesculin, Barringtogenol-C21-angelat, 14- Dehydroagrostistachin, Agroskerin, Agrostistachin, 17-Hydroxyagrostistachin, Ovatodiolide, 4,7-Oxycycloanisomelsäure, Baccharinoide B1, B2, B3 und B7, Tubeimosid, Bruceantinoside C, Yadanzioside N, und P, Isodeoxyelephantopin, Tomenphantopin A und B, Coronarin A,B,C und D, Ursolsäure, Hyptatsäure A, Iso-Iridogermanal. Maytenfoliol, Effusantin A, Excisanin A und B, Longikaurin B, Sculponeatin C, Kamebaunin, Leukamenin A und B, 13,18-Dehydro-6-alpha-Senecioyloxychaparrin, Taxamairin A und B, Regenilol, Triptolid, des weiteren Cymarin, Hydroxyanopterin, Protoanemonin, Cheliburinchlorid, Sinococulin A und B, Dihydronitidin, Nitidinchlorid, 12-beta-Hydroxypregnadien 3,20-dion, Helenalin, Indicin, Indicin-N-oxid, Lasiocarpin, Inotodiol,, Podophyllotoxin, Justicidin A und B, Larreatin, Malloterin, Mallotochromanol, Isobutyrylmallotochromanol, Maquirosid A, Marchantin A, Maytansin, Lycoridicin, Margetin, Pancratistatin, Liriodenin, Bispsrthenolidin, Oxoushinsunin, Periplocosid A, Ursolsäure, Deoxypsorospermin, Psycorubin, Ricin A, Sanguinarin, Manwuweizsäure, Methylsorbifolin, Sphatheliachromen, Stizophyllin, Mansonin, Streblosid, Dihydrousambaraensin, Hydroxyusambarin, Strychnopentamin, Strychnophyllin, Usambarin, Usambarensin, Liriodenin, Oxoushinsunin, Daphnoretin, Lariciresinol, Methoxylariciresinol, Syringaresinol, Sirolimus (Rapamycin), Somatostatin, Tacrolimus, Roxithromycin, Troleandomycin, Simvastatin, Rosuvastatin, Vinblastin, Vincristin, Vindesin, Teniposid, Vinorelbin, Tropfosfamid, Treosulfan, Tremozolomid, Thiotepa, Tretinoin, Spiramycin, Umbelliferon, Desacetylvismion A, Vismion A und B, Zeorin.As antiproliferative, anti-inflammatory and / or antifungal agents, for example, those selected from the following list:
Abciximab, Acemetacin, Acetylvismion B, Aclarubicin, Ademetionin, Adriamycin, Aescin, Afromosone, Akagerin, Aldesleukin, Amidorone, Aminoglutethemide, Amsacrine, Anakinra, Anastrozole, Anemonin, Anopterin, Antifungals, Antithrombotics, Apocymarin, Argatroban, Aristolactam-All, Aristolochic Acid, Ascomycin , Asparaginase, aspirin, atorvastatin, auranofin, azathioprine, azithromycin, baccatin, bafilomycin, basiliximab, bendamustine, benzocaine, berberine, betulin, betulinic acid, bilobol, bisparthenolidine, bleomycin, bombrestatin, boswellic acids and their derivatives, bruceanols A, B and C, bryophyllin A, busulfan, antithrombin, bivalirudin, cadherins, camptothecin, capecitabine, o-carbamoylphenoxyacetic acid, carboplatin, carmustine, celecoxib, cepharantin, cerivastatin, CETP inhibitors, chlorambucil, chloroquine phosphate, cictoxin, ciprofloxacin, cisplatin, cladribine, clarithromycin, colchicine, concanamycin, Coumadin, C-type Natriuretic Peptide (CNP), cudraisoflavone A, curcumin, cyclophosphamide, cyclos porin A, cytarabine, dacarbazine, daclizumab, dactinomycin, dapsone, daunorubicin, diclofenac, 1,11-dimethoxycanthin-6-one, docetaxel, doxorubicin, dunaimycin, epirubicin, epothilones A and B, erythromycin, estramustine, etoboside, everolimus, filgrastim, Fluroblastin, fluvastatin, fludarabine, fludarabine 5'-dihydrogen phosphate, fluorouracil, folimycin, fosfestrol, gemcitabine, ghalacinoside, ginkgol, ginkgolic acid, glycoside 1a, 4-hydroxyoxycyclophosphamide, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, midecamycin, Mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan, topotecan, hydroxycarbamide, miltefosine, pentostatin, pegasparase, exemestane, letrozole, formestan, SMC proliferation inhibitor-2w, mitoxanthrone, mycophenolate mofetil, c-myc antisense, β-myc antisense, β-lapachone, podophyllotoxin, podophyllic acid 2-ethylhydrazide, molgramostim (rhuGM-CSF), peginterferon α-2b, Lanograst in (r-HuG-CSF), macrogol, selectin (cytokinan antagonist, probucol, prostaglandins, 1-hydroxy-11-methoxycanthin-6-one, scopolectin, NO donors such as pentaerythrityl tetranitrate and syndnoeimines, S-nitrosated derivatives, tamoxifen, staurosporine, β-estradiol, α-estradiol, estriol, estrone, ethinylestradiol, medroxyprogesterone, estradiol cypionates, estradiol benzoates, tranilast, camebakaurin and other terpenoids used in cancer therapy, verapamil, tyrosine kinase Inhibitors (tyrphostins), paclitaxel and its derivatives such as 6-α-hydroxy-paclitaxel, taxoters, carbon suboxide (MCS) and its macrocyclic oligomers, mofebutazone, lonazolac, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, sodium aurothiomalate, Oxaceprol, β-sitosterol, Myrtecain, Polidocanol, Nonivamide, Levomenthol, Ellipticin, D-24851 (Calbiochem), Colcemid, Cytochalasin AE, Ind anocine, nocadazole, S 100 protein, bacitracin, vitronectin receptor antagonist, azelastine, guanidyl cyclase stimulator tissue proteinase 1 and 2 tissue inhibitor, free nucleic acids, nucleic acids incorporated into virus carriers, DNA and RNA fragments, plaminogen activator inhibitor-1, Plasminogen activator inhibitor-2, antisense oligonucleotides, VEGF inhibitors, IGF-1, drugs from the group of antibiotics such as cefadroxil, cefazolin, cefaclor, cefotixine tobramycin, gentamycin, penicillins such as dicloxacillin, oxacillin, sulfonamides, metronidazole, enoxoparin, desulfated and N-reacetylated heparin (hemoparin ®), tissue plasminogen activator, GpIIb / IIIa platelet membrane receptor, factor X a inhibitor antibody, heparin, hirudin, r-hirudin, PPACK, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators such as Dipyramidole, trapidil, nitroprusside, PDGF antagonists such as triazolopyrimidine and seramin, ACE inhibitors such as captopril, cilazapril, lisinopril , Enalapril, losartan, thioprotease inhibitors, prostacyclin, vapiprost, interferon α, β and γ, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis regulators such as p65, NF-kB or Bcl-xL antisense oligonucleotides, halofuginone, nifedipine, tocopherol tranilast, molsidomine, tea polyphenols , Epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, etoposide, dicloxacylline, tetracycline, triamcinolone, mutamycin, procainimide, retinoic acid, quinidine, disopyrimide, flecainide, propafenone, sotolol, natural and synthetic steroids such as inotodiol, maquiroside A, ghalakinoside, mansonine, Strebloside, hydrocortisone, betamethasone, dexamethasone, nonsteroidal substances (NSAIDS) such as fenoporfen, ibuprofen, indomethacin, naproxen, phenylbutazone and other antiviral agents such as acyclovir, ganciclovir and zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprozoic agents like chloroquine, mefloquine , Quinine, and also natural terpenoids such as hippocaesculin, barringtogenol C21-angelate, 14-dehydroagrostistachine, agroscerin, agrostistachin, 17-hydroxyagrostistachine, ovatodiolides, 4,7-oxycycloanisomelic acid, baccharinoids B1, B2, B3 and B7, tubeimoside, bruceantinoside C, Yadanziosides N, and P, isodeoxyelephantopin, tomenphantopin A and B, coronary A, B, C and D, ursolic acid, hyptate acid A, iso-iridogermanal. Maytenfoliol, Effusantin A, Excisanin A and B, Longikaurin B, Sculponeatin C, Kamebaunin, Leukamenin A and B, 13,18-Dehydro-6-alpha-Senecioyloxychaparrin, Taxamairin A and B, Regenilol, Triptolide, Cymarin, Hydroxyanopterin, Protoanemonin, cheliburine chloride, sinococulin A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxypregnadiene 3,20-dione, helenaline, indicin, indicin-N-oxide, lasiocarpine, inotodiol ,, podophyllotoxin, justicidin A and B, larreatin, malloterin, Mallotochromanol, Isobutyrylmallotochromanol, Maquiroside A, Marchantin A, Maytansin, Lycoridicin, Margetin, Pancratistatin, Liriodenin, Bispsrthenolidine, Oxoushinsunin, Periplocoside A, Ursolic Acid, Deoxypypsorospermine, Psycorubin, Ricin A, Sanguinarine, Manuwic Acid, Methylsorbifoline, Sphatheliachromes, Stizophyllin, Mansonine, Strebloside, Dihydrousambaraensin, Hydroxyusambarin, Strychnopentamine, Strychnophyllin, Usambarin, Usambarensin, Liriodenin, Oxoushinsunin, Daphnoretin, Lariciresinol, Methoxylariciresinol, Syringaresinol, Sirolimus (rapamycin), Somatostatin, Tacrolimus, Roxithromycin, Troleandomycin, Simvastatin, Rosuvastatin, Vinblastine, Vincristine, Vindesine, Teniposide, Vinorelbine, Tropfosfamide, Treosulfan, Tremozolomide, Thiotepa, Tretinoin, Spiramycin, Umbelliferone, Desacetylvismion A, Vismion A and B , Zeorin.

Der Wirkstoff kann in reiner Form oder zusammen mit einem Polymer aufgebracht werden. Für die Aufbringung werden bevorzugt Tauch- oder Sprühverfahren eingesetzt.Of the Active substance can be applied in pure form or together with a polymer become. For the Application preferably dipping or spraying methods are used.

Ferner kann der antiproliferative, antiinflammatorische und/oder antimykotische Wirkstoff in einer Polymermatrix eingebettet werden oder sich unter oder auch auf einer Polymermatrix befinden.Further may be the antiproliferative, anti-inflammatory and / or antifungal Active substance embedded in a polymer matrix or under or on a polymer matrix.

Zudem kann sich noch eine weitere polymere biostabile oder bioabbaubare Schicht zusätzlich zu der Polymermatrix auf dem Stent befinden. Auch diese Schicht kann einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff enthalten, der gleich oder verschieden von dem Wirkstoff in der Polymermatrix sein kann.moreover may be yet another polymeric biostable or biodegradable Layer in addition to the polymer matrix on the stent. Also this layer may be an antiproliferative, anti-inflammatory and / or antifungal Contain active substance that is the same or different from the active substance in the polymer matrix.

Bei einer bevorzugten Ausführungsform befindet sich auf der Oberfläche des Stent ein anderer oder zusätzlicher Wirkstoff wie auf der Oberfläche des Ballons. Bevorzugte Wirkstoffe, welche sich auf der Oberfläche des Stent befinden können, werden ausgewählt aus der Gruppe der antiinflammatorischen Wirkstoffe und insbesondere der Cortikosteroide. Insbesondere ist bevorzugt, wenn der Stent auf seiner Oberfläche Dexamethason mit oder ohne polymere Matrix aufweist und sich auf dem Ballon einer der vorgenannten antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoffe befindet. Es sei nochmals erwähnt, dass der oder die Wirkstoffe in einer polymeren Matrix eingebettet oder pur oder überzogen mit einer polymeren Schicht auf dem Ballon und Stent anwesend sein können.In a preferred embodiment, another or additional active agent is present on the surface of the stent as on the surface of the balloon. Preferred active ingredients which may be present on the surface of the stent are selected from the group of antiinflammatory agents and in particular the corticosteroid ide. In particular, it is preferred if the stent has dexamethasone on its surface, with or without a polymeric matrix, and if one of the aforementioned antiproliferative, antiinflammatory and / or antimycotic active substances is present on the balloon. It should be reiterated that the active agent (s) may be embedded in a polymeric matrix or present neat or coated with a polymeric layer on the balloon and stent.

Als biostabile oder bioabbaubare Polymere und/oder Polymere für die Polymermatrix können folgende Substanzen eingesetzt werden:
Polyvalerolactone, Poly-ε-Decalactone, Polylactonsäure, Polyglycolsäure Polylactide, Polyglycolide, Copolymere der Polylactide und Polyglycolide, Poly-ε-caprolacton, Polyhydroxybuttersäure, Polyhydroxybutyrate, Polyhydroxyvalerate, Polyhydroxybutyrate-co-valerate, Poly(1,4-dioxan-2,3-dione), Poly(1,3-dioxan-2-one), Poly-para-dioxanone, Polyanhydride, Polymaleinsäureanhydride, Polyhydroxymethacrylate, Fibrin, Polycyanoacrylate, Polycaprolactondimethylacrylate, Poly-β-Maleinsäure Polycaprolactonbutylacrylate, Multiblockpolymere aus Oligocaprolactondiole und Oligodioxanondiole, Polyetherestermultiblockpolymere aus PEG und Polybutylenterephtalat, Polypivotolactone, Polyglycolsäuretrimethylcarbonate Polycaprolactonglycolide, Poly(γ-ethylglutamat), Poly(DTH-Iminocarbonat), Poly(DTE-co-DT-carbonat), Poly(Bisphenol A-iminocarbonat), Polyorthoester, Polyglycolsäuretrimethylcarbonate, Polytrimethylcarbonate Polyiminocarbonate, Poly(N-vinyl)-Pyrrolidon, Polyvinylalkohole, Polyesteramide, glycolierte Polyester, Polyphosphoester, Polyphosphazene, Poly[p-carboxyphenoxy)propan], Polyhydroxypentansäure, Polyanhydride, Polyethylenoxidpropylenoxid, weiche Polyurethane, Polyurethane mit Aminosäurereste im Backbone, Polyetherester wie das Polyethylenoxid, Polyalkenoxalate, Polyorthoester sowie deren Copolymere, Lipide, Carrageenane, Fibrinogen, Stärke, Kollagen, protein-basierende Polymere, Polyaminosäuren, synthetische Polyaminosäuren, Zein, Polyhydroxyalkanoate, Pectinsäure, Actinsäure, Carboxymethylsulfat, Albumin, Hyaluronsäure, Chitosan und seine Derivate, Heparansulfate und seine Derivate, Heparine, Chondroitinsulfat, Dextran, β-Cyclodextrine, Copolymere mit PEG und Polypropylenglycol, Gummi arabicum, Guar, Gelatine, Collagen Collagen-N-Hydroxysuccinimid, Lipide, Phospholipide, Polyacrylsäure, Polyacrylate, Polymethylmethacrylat, Polybutylmethacrylat, Polyacrylamid, Polyacrylonitrile, Polyamide, Polyetheramide, Polyethylenamin, Polyimide, Polycarbonate, Polycarbourethane, Polyvinylketone, Polyvinylhalogenide, Polyvinylidenhalogenide, Polyvinylether, Polyisobutylene, Polyvinylaromaten, Polyvinylester, Polyvinylpyrollidone, Polyoxymethylene, Polytetramethylenoxid, Polyethylen, Polypropylen, Polytetrafluorethylen, Polyurethane, Polyetherurethane, Silicon-Polyetherurethane, Silicon-Polyurethane, Silicon-Polycarbonat-Urethane, Polyolefin-Elastomere, Polyisobutylene, EPDM-Gummis, Fluorosilicone, Carboxymethylchitosane, Polyaryletheretherketone, Polyetheretherketone, Polyethylenterephtalat, Polyvalerate, Carboxymethylcellulose, Cellulose, Rayon, Rayontriacetate, Cellulosenitrate, Celluloseacetate, Hydroxyethylcellulose, Cellulosebutyrate, Celluloseacetatbutyrate, Ethylvinylacetat-copolymere, Polysulfone, Epoxyharze, ABS-Harze, EPDM-Gummis, Silicone wie Polysiloxane, Polydimethylsiloxane, Polyvinylhalogene und Copolymere, Celluloseether, Cellulosetriacetate, Chitosane und Copolymere und/oder Mischungen der vorgenannten Polymere.The following substances can be used as biostable or biodegradable polymers and / or polymers for the polymer matrix:
Polyvalerolactones, poly-ε-decalactones, polylactic acid, polyglycolic acid polylactides, polyglycolides, copolymers of polylactides and polyglycolides, poly-ε-caprolactone, polyhydroxybutyric acid, polyhydroxybutyrates, polyhydroxyvalerates, polyhydroxybutyrate-co-valerates, poly (1,4-dioxane-2,3 -diones), poly (1,3-dioxan-2-ones), poly-para-dioxanones, polyanhydrides, polymaleic anhydrides, polyhydroxymethacrylates, fibrin, polycyanoacrylates, polycaprolactone dimethyl acrylates, poly-β-maleic acid, polycaprolactone butylacrylates, multiblock polymers of oligocaprolactone diols and oligodioxanonediols, polyetherester multiblock polymers PEG and polybutylene terephthalate, polypivotolactones, polyglycolic acid trimethylcarbonates, polycaprolactone glycolides, poly (γ-ethylglutamate), poly (DTH-iminocarbonate), poly (DTE-co-DT-carbonate), poly (bisphenol A-iminocarbonate), polyorthoester, poly (triglycyl) poly (trimethyl) carbonate, poly (trimethyl) carbonate, polyiminocarbonate, poly (N-vinyl) pyrrolidone, polyvinyl alcohols, polyester amide e, glycolated polyesters, polyphosphoesters, polyphosphazenes, poly [p-carboxyphenoxy) propane], polyhydroxypentanoic acid, polyanhydrides, polyethylene oxide-propylene oxide, soft polyurethanes, polyurethanes with amino acid residues in the backbone, polyether esters such as polyethylene oxide, polyalkene oxalates, polyorthoesters and their copolymers, lipids, carrageenans, fibrinogen , Starch, collagen, protein-based polymers, polyamino acids, synthetic polyamino acids, zein, polyhydroxyalkanoates, pectinic acid, actinic acid, carboxymethylsulfate, albumin, hyaluronic acid, chitosan and its derivatives, heparan sulfates and its derivatives, heparins, chondroitin sulfate, dextran, β-cyclodextrins, copolymers with PEG and polypropylene glycol, gum arabic, guar, gelatin, collagen, collagen N-hydroxysuccinimide, lipids, phospholipids, polyacrylic acid, polyacrylates, polymethylmethacrylate, polybutylmethacrylate, polyacrylamide, polyacrylonitriles, polyamides, polyetheramides, polyethyleneamine, polyimides, polycarbonates, polyc arbourethanes, polyvinyl ketones, polyvinyl halides, polyvinylidene halides, polyvinyl ethers, polyisobutylenes, polyvinyl aromatics, polyvinyl esters, polyvinyl pyrollidones, polyoxymethylenes, polytetramethylene oxide, polyethylene, polypropylene, polytetrafluoroethylene, polyurethanes, polyether urethanes, silicone polyether urethanes, silicone polyurethanes, silicone polycarbonate urethanes, polyolefin elastomers, Polyisobutylenes, EPDM rubbers, fluorosilicones, carboxymethylchitosans, polyaryletheretherketones, polyetheretherketones, polyethylene terephthalate, polyvalerates, carboxymethylcellulose, cellulose, rayon, rayontriacetates, cellulose nitrates, cellulose acetates, hydroxyethylcellulose, cellulose butyrates, cellulose acetate butyrates, ethylvinylacetate copolymers, polysulphones, epoxy resins, ABS resins, EPDM Gums, silicones such as polysiloxanes, polydimethylsiloxanes, polyvinylhalogens and copolymers, cellulose ethers, cellulose triacetates, chitosans and copolymers and / or mixtures of the abovementioned polymers.

Die erfindungsgemäßen beschichteten Ballons mit aufgesetztem Stent, welche auf ihrer Oberfläche mindestens einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff aufweisen, können hergestellt werden, indem man einen Ballon geeignet für einen Dilatationskatheter mit oder ohne Katheter bereitstellt und einen Stent in nicht expandierter Form auf den Ballon aufsetzt.The Coated according to the invention Balloons with an attached stent, which on their surface at least an antiproliferative, anti-inflammatory and / or antifungal Active substance may have be prepared by having a balloon suitable for one Provides dilatation catheter with or without catheter and one Stent is placed in unexpanded form on the balloon.

Das so erhaltene System ist für die Implantation des Stent geeignet. Bevor jedoch der Stent implantiert wird, werden Ballon und Stent zusammen mit mindestens einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichtet, wobei der Wirkstoff in reiner Form beispielsweise als wäßrige oder alkoholische Lösung im Sprüh oder Tauchverfahren oder zusammen mit einem Polymeren aufgebracht werden kann. Vor oder nach der Auftragung des Wirkstoffs mit oder ohne polymere Matrix besteht die Möglichkeit, eine weitere biostabile oder bioabbaubare Schicht auf den Stent und Ballon aufzubringen.The thus obtained system is for the implantation of the stent suitable. Before, however, the stent is implanted balloon and stent together with at least one antiproliferative, coated with anti-inflammatory and / or antifungal agent, wherein the active ingredient in pure form, for example as aqueous or alcoholic solution in the spray or dipping method or applied together with a polymer can be. Before or after application of the active substance with or without polymeric matrix there is the possibility of another biostable or biodegradable layer on the stent and balloon.

Das erfindungsgemäße Verfahren bietet den entscheidenden Vorteil, dass Ballon und Stent gemeinsam eine röhrenförmige Oberfläche bilden und die gesamte Oberfläche mit mindestens einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichtet wird. Dies ermöglicht die Aufbringung von absolut deutlich mehr Wirkstoff auf die Gesamtoberfläche als man nur auf die Stentoberfläche hätte aufbringen können.The inventive method offers the crucial advantage that balloon and stent work together to form a tubular surface and the entire surface with at least one antiproliferative, anti-inflammatory and / or antifungal agent is coated. This allows the Application of significantly more active ingredient on the total surface than one only on the stent surface would have to raise can.

Ferner wird nur die der Gefäßwand zugewandte Oberfläche des Stent mit Wirkstoff beschichtet und die Innenoberfläche des Stent, welche nicht mit der Gefäßwand in Kontakt kommt, wird nicht unnötig mit Wirkstoff beschichtet, der an dieser Stelle keine Funktion hat.Further only the one facing the vessel wall becomes surface The stent is coated with active substance and the inner surface of the stent Stent, which does not interfere with the vascular wall Contact comes, does not become unnecessary coated with active substance, which has no function at this point.

Wesentlich ist, dass das System aus Ballon mit aufgesetztem Stent als Einheit beschichtet wird. Dabei können diverse herkömmliche Ballons sowie Stents eingesetzt werden. Der verwendete Stent kann aus medizinischem Edelstahl, Titan, Chrom, Vanadium, Wolfram, Molybdän, Gold oder Nitinol bestehen. Ferner kann der aufgesetzt Stent bereits beschichtet oder unbeschichtet sein. Auch Stents mit einer biostabilen, bioabbaubaren und/oder hämokompatiblen Schicht können eingesetzt werden.It is essential that the system of balloon with attached stent is coated as a unit. Various conventional balloons and stents can be used. The stent used may be made of medical grade stainless steel, titanium, chromium, vanadium, tungsten, molybdenum, gold or nitinol stand. Furthermore, the attached stent may already be coated or uncoated. Stents with a biostable, biodegradable and / or hemocompatible layer can also be used.

Bei der Implantation ergibt sich nun der Vorteil, dass bei der Expansion zumindest für kurze Zeit die Oberfläche des Ballons und der Stent gegen die Gefäßwand gedrückt werden. Diese Expansion erfüllt gleichzeitig zwei Aufgaben. Zum einen wird der Stent expandiert und somit in seine Endform und Lage gebracht und zum anderen wird der Wirkstoff mit oder ohne Matrix von der Ballonoberfläche auf die Gefäßwand übertragen.at The implantation now gives the advantage that during expansion at least for short time the surface of the balloon and the stent are pressed against the vessel wall. This expansion Fulfills at the same time two tasks. First, the stent is expanded and thus brought into its final form and position and becomes another the drug with or without matrix from the balloon surface transfer the vessel wall.

Dies führt dazu, dass nicht nur dort die Gefäßinnenwand mit Wirkstoff versorgt wird, wo der Stent bzw. das Stentgerüst an die Gefäßwand anliegt, sondern auch die Zwischenräume zwischen dem Stentgerüst über die Oberfläche des Ballons mit Wirkstoff versorgt werden.This leads to, that not only there the inner wall of the vessel is supplied with active substance, where the stent or the stent framework to the Vessel wall is present, but also the gaps between the stent framework over the surface be supplied with active substance of the balloon.

Der von der Ballonoberfläche auf die Gefäßinnenwand bei der Dilatation übertragene Wirkstoff liegt in hoher Konzentration vor und wird relativ schnell verbraucht.Of the from the balloon surface on the vessel inner wall transferred during dilatation Active ingredient is present in high concentration and is relatively fast consumed.

Diese Vorgehensweise führt jedoch dazu, dass die gesamte Gefäßinnenwand entlang der Lage des Stent für die erste Woche nach Stentimplantation mit einer ausreichenden Menge an antiproliferativem, antiinflammatorischem und/oder antimykotischem Wirkstoff versorgt wird.These Procedure leads however, that the entire vessel inner wall along the location of Stent for the first week after stent implantation with a sufficient amount an anti-proliferative, anti-inflammatory and / or antimycotic agent is supplied.

Die Freisetzungskinetik des auf der Stentoberfläche aufgetragenen Wirkstoffs dann durchaus deutlich länger als eine Woche andauern.The Release kinetics of the drug applied to the stent surface then definitely longer last than a week.

Ferner ist für die polymere Matrix oder einer zusätzlichen oberen biostabilen oder bioabbaubaren Schicht die Verwendung eines Polymeren bevorzugt, welches eine besonderes hohe Affinität zur Zellinnenwand bzw. den Endothel- und Muskelzellen der Zellinnenwand aufweist.Further is for the polymeric matrix or an additional upper biostable or biodegradable layer, the use of a polymer is preferred a special high affinity to the cell wall or the endothelial and muscle cells of the cell wall having.

Das System aus beschichtetem Ballon und Stent eignet sich hervorragend zur Verhinderung oder Reduzierung von Restenose.The System of coated balloon and stent is ideal to prevent or reduce restenosis.

Das erfindungsgemäße Coronarstentsystem umfasst zumindest einen Ballon und einen Stent in nicht-expandierter Form. Ferner kann das System noch einen Katheter umfassen, so dass die Möglichkeit besteht, ein erfindungsgemäß beschichtetes System aus Ballon mit aufgesetztem Stent und ohne Katheter oder ein erfindungsgemäß beschichtetes System aus Ballon mit Katheter und aufgesetztem Stent bereitzustellen und zu vermarkten.The Coronary stent system according to the invention comprises at least one balloon and one stent in unexpanded form. Furthermore, the system may further comprise a catheter, so that the possibility there is a system coated according to the invention balloon with attached stent and without catheter or a system coated according to the invention to provide balloon with catheter and attached stent and market.

Claims (10)

Expandierbarer Ballon mit einem aufgesetzten Stent, wobei Ballon und Stent mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichtet sind.Expandable balloon with an attached stent, wherein balloon and stent are provided with at least one antiproliferative, coated anti-inflammatory and / or antifungal agent are. Expandierbarer Ballon nach Anspruch 1, wobei der antiproliferative, antiinflammatorische und/oder antimykotische Wirkstoff aus der Gruppe ausgewählt wird umfassend: Abciximab, Acemetacin, Acetylvismion B, Aclarubicin, Ademetionin, Adriamycin, Aescin, Afromoson, Akagerin, Aldesleukin, Amidoron, Aminoglutethemid, Amsacrin, Anakinra, Anastrozol, Anemonin, Anopterin, Antimykotika, Antithrombotika, Apocymarin, Argatroban, Aristolactam-All, Aristolochsäure, Ascomycin, Asparaginase, Aspirin, Atorvastatin, Auranofin, Azathioprin, Azithromycin, Baccatin, Bafilomycin, Basiliximab, Bendamustin, Benzocain, Berberin, Betulin, Betulinsäure, Bilobol, Bisparthenolidin, Bleomycin, Bombrestatin, Boswellinsäuren und ihre Derivate, Bruceanole A,B und C, Bryophyllin A, Busulfan, Antithrombin, Bivalirudin, Cadherine, Camptothecin, Capecitabin, o-Carbamoylphenoxyessigsäure, Carboplatin, Carmustin, Celecoxib, Cepharantin, Cerivastatin, CETP-Inhibitoren, Chlorambucil, Chloroquinphosphat, Cictoxin, Ciprofloxacin, Cisplatin, Cladribin, Clarithromycin, Colchicin, Concanamycin, Coumadin, C-Type Natriuretic Peptide (CNP), Cudraisoflavon A, Curcumin, Cyclophosphamid, Cyclosporin A, Cytarabin, Dacarbazin, Daclizumab, Dactinomycin, Dapson, Daunorubicin, Diclofenac, 1,11-Dimethoxycanthin-6-on, Docetaxel, Doxorubicin, Dunaimycin, Epirubicin, Epothilone A und B, Erythromycin, Estramustin, Etobosid, Everolimus, Filgrastim, Fluroblastin, Fluvastatin, Fludarabin, Fludarabin-5'-dihydrogenphosphat, Fluorouracil, Folimycin, Fosfestrol, Gemcitabin, Ghalakinosid, Ginkgol, Ginkgolsäure, Glykosid 1a, 4-Hydroxyoxycyclophosphamid, Idarubicin, Ifosfamid, Josamycin, Lapachol, Lomustin, Lovastatin, Melphalan, Midecamycin, Mitoxantron, Nimustin, Pitavastatin, Pravastatin, Procarbazin, Mitomycin, Methotrexat, Mercaptopurin, Thioguanin, Oxaliplatin, Irinotecan, Topotecan, Hydroxycarbamid, Miltefosin, Pentostatin, Pegasparase, Exemestan, Letrozol, Formestan, SMC-Proliferation-Inhibitor-2w, Mitoxanthrone, Mycophenolatmofetil, c-myc-Antisense, β-myc-Antisense, β-Lapachon, Podophyllotoxin, Podophyllsäure-2-ethylhydrazid, Molgramostim (rhuGM-CSF), Peginterferon α-2b, Lanograstim (r-HuG-CSF), Macrogol, Selectin (Cytokinantagonist), Cytokininhibitoren, COX-2-Inhibitor, NFkB, Angiopeptin, monoklonale Antikörper, die die Muskelzellproliferation hemmen, bFGF-Antagonisten, Probucol, Prostaglandine, 1-Hydroxy-11- Methoxycanthin-6-on, Scopolectin, NO-Donoren wie Pentaerythrityltetranitrat und Syndnoeimine, S-Nitrosoderivate, Tamoxifen, Staurosporin, β-Estradiol, α-Estradiol, Estriol, Estron, Ethinylestradiol, Medroxyprogesteron, Estradiolcypionate, Estradiolbenzoate, Tranilast, Kamebakaurin und andere Terpenoide, die in der Krebstherapie eingesetzt werden, Verapamil, Tyrosin-Kinase-Inhibitoren (Tyrphostine), Paclitaxel und dessen Derivate wie 6-α-Hydroxy-Paclitaxel, Taxotere, Kohlensuboxids (MCS) und dessen macrocyclische Oligomere, Mofebutazon, Lonazolac, Lidocain, Ketoprofen, Mefenaminsäure, Piroxicam, Meloxicam, Penicillamin, Hydroxychloroquin, Natriumaurothiomalat, Oxaceprol, β-Sitosterin, Myrtecain, Polidocanol, Nonivamid, Levomenthol, Ellipticin, D-24851 (Calbiochem), Colcemid, Cytochalasin A-E, Indanocine, Nocadazole, S 100 Protein, Bacitracin, Vitronectin-Rezeptor Antagonisten, Azelastin, Guanidylcyclase-Stimulator Gewebsinhibitor der Metallproteinase-1 und 2, freie Nukleinsäuren, Nukleinsäuren in Virenüberträger inkorporiert, DNA- und RNA-Fragmente, Plaminogen-Aktivator Inhibitor-1, Plasminogen-Aktivator Inhibitor-2, Antisense Oligonucleotide, VEGF-Inhibitoren, IGF-1, Wirkstoffe aus der Gruppe der Antibiotika wie Cefadroxil, Cefazolin, Cefaclor, Cefotixin Tobramycin, Gentamycin, Penicilline wie Dicloxacillin, Oxacillin, Sulfonamide, Metronidazol, Enoxoparin, desulfatiertes und N-reacetyliertes Heparin (Hemoparin®), Gewebe-Plasminogen-Aktivator, GpIIb/IIIa-Plättchenmembranrezeptor, Faktor Xa-Inhibitor Antikörper, Heparin, Hirudin, r-Hirudin, PPACK, Protamin, Prourokinase, Streptokinase, Warfarin, Urokinase, Vasodilatoren wie Dipyramidol, Trapidil, Nitroprusside, PDGF-Antagonisten wie Triazolopyrimidin und Seramin, ACE-Inhibitoren wie Captopril, Cilazapril, Lisinopril, Enalapril, Losartan, Thioproteaseinhibitoren, Prostacyclin, Vapiprost, Interferon α, β und γ, Histaminantagonisten, Serotoninblocker, Apoptoseinhibitoren, Apoptoseregulatoren wie p65, NF-kB oder Bcl-xL-Antisense-Oligonukleotiden, Halofuginon, Nifedipin, Tocopherol Tranilast, Molsidomin, Teepolyphenole, Epicatechingallat, Epigallocatechingallat, Leflunomid, Etanercept, Sulfasalazin, Etoposid, Dicloxacyllin, Tetracyclin, Triamcinolon, Mutamycin, Procainimid, Retinolsäure, Quinidin, Disopyrimid, Flecainid, Propafenon, Sotolol, natürliche und synthetisch hergestellte Steroide wie Inotodiol, Maquirosid A, Ghalakinosid, Mansonin, Streblosid, Hydrocortison, Betamethason, Dexamethason, nichtsteroidale Substanzen (NSAIDS) wie Fenoporfen, Ibuprofen, Indomethacin, Naproxen, Phenylbutazon und andere antivirale Agentien wie Acyclovir, Ganciclovir und Zidovudin, Clotrimazol, Flucytosin, Griseofulvin, Ketoconazol, Miconazol, Nystatin, Terbinafin, antiprozoale Agentien wie Chloroquin, Mefloquin, Quinin, des weiteren natürliche Terpenoide wie Hippocaesculin, Barringtogenol-C21-angelat, 14- Dehydroagrostistachin, Agroskerin, Agrostistachin, 17-Hydroxyagrostistachin, Ovatodiolide, 4,7-Oxycycloanisomelsäure, Baccharinoide B1, B2, B3 und B7, Tubeimosid, Bruceantinoside C, Yadanzioside N, und P, Isodeoxyelephantopin, Tomenphantopin A und B, Coronarin A,B,C und D, Ursolsäure, Hyptatsäure A, Iso-Iridogermanal. Maytenfoliol, Effusantin A, Excisanin A und B, Longikaurin B, Sculponeatin C, Kamebaunin, Leukamenin A und B, 13,18-Dehydro-6-alpha-Senecioyloxychaparrin, Taxamairin A und B, Regenilol, Triptolid, des weiteren Cymarin, Hydroxyanopterin, Protoanemonin, Cheliburinchlorid, Sinococulin A und B, Dihydronitidin, Nitidinchlorid, 12-beta-Hydroxypregnadien 3,20-dion, Helenalin, Indicin, Indicin-N-oxid, Lasiocarpin, Inotodiol,, Podophyllotoxin, Justicidin A und B, Larreatin, Malloterin, Mallotochromanol, Isobutyrylmallotochromanol, Maquirosid A, Marchantin A, Maytansin, Lycoridicin, Margetin, Pancratistatin, Liriodenin, Bispsrthenolidin, Oxoushinsunin, Periplocosid A, Ursolsäure, Deoxypsorospermin, Psycorubin, Ricin A, Sanguinarin, Manwuweizsäure, Methylsorbifolin, Sphatheliachromen, Stizophyllin, Mansonin, Streblosid, Dihydrousambaraensin, Hydroxyusambarin, Strychnopentamin, Strychnophyllin, Usambarin, Usambarensin, Liriodenin, Oxoushinsunin, Daphnoretin, Lariciresinol, Methoxylariciresinol, Syringaresinol, Sirolimus (Rapamycin), Somatostatin, Tacrolimus, Roxithromycin, Troleandomycin, Simvastatin, Rosuvastatin, Vinblastin, Vincristin, Vindesin, Teniposid, Vinorelbin, Tropfosfamid, Treosulfan, Tremozolomid, Thiotepa, Tretinoin, Spiramycin, Umbelliferon, Desacetylvismion A, Vismion A und B, Zeorin.The expandable balloon of claim 1, wherein the antiproliferative, anti-inflammatory and / or antifungal agent is selected from the group comprising: abciximab, acemetacin, acetylvismion B, aclarubicin, ademetionin, adriamycin, aescin, afromosone, akagerin, aldesleukin, amidorone, aminoglutethemide, amsacrine, Anakinra, anastrozole, anemonin, anopterin, antifungals, antithrombotics, apocymarin, argatroban, aristolactam-all, aristolochic acid, ascomycin, asparaginase, aspirin, atorvastatin, auranofin, azathioprine, azithromycin, baccatin, bafilomycin, basiliximab, bendamustine, benzocaine, berberine, betulin, Betulinic acid, bilobol, bis-parthenolidine, bleomycin, bombrestatin, boswellic acids and their derivatives, bruceanols A, B and C, bryophyllin A, busulfan, antithrombin, bivalirudin, cadherins, camptothecin, capecitabine, o-carbamoylphenoxyacetic acid, carboplatin, carmustine, celecoxib, cepharantin, cerivastatin , CETP inhibitors, chlorambucil, chloroquine phosphate, cictoxin, ciprofl oxacin, cisplatin, cladribine, clarithromycin, colchicine, concanamycin, coumadin, C-type natriuretic peptides (CNP), cudraisoflavone A, curcumin, cyclophosphamide, cyclosporin A, cytarabine, dacarbazine, daclizumab, dactinomycin, dapsone, daunorubicin, diclofenac, 1,11 -Dimethoxycanthin-6-one, docetaxel, doxorubicin, dunaimycin, epirubicin, epothilones A and B, erythromycin, estramustine, etoboside, everolimus, filgrastim, fluroblastin, fluvastatin, fludarabine, fludarabine-5'-dihydrogenphosphate, fluorouracil, folimycin, fosfestrol, gemcitabine , Ghalacinoside, ginkgol, ginkgolic acid, glycoside 1a, 4-hydroxyoxycyclophosphamide, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, midecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, Irinotecan, topotecan, hydroxycarbamide, miltefosine, pentostatin, pegasparase, exemestane, letrozole, formestan, SMC proliferation inhibitor-2w, mitoxanthrone, mycopheno latmofetil, c-myc antisense, β-myc antisense, β-lapachone, podophyllotoxin, podophyllic acid 2-ethyl hydrazide, molgramostim (rhuGM-CSF), peginterferon α-2b, lanograstim (r-HuG-CSF), macrogol, selectin (Cytokine antagonist), cytokine inhibitors, COX-2 inhibitor, NFkB, angiopeptin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydroxy-11-methoxycanthin-6-one, scopolectin, NO donors such as Pentaerythrityl tetranitrate and syndnoeimines, S-nitrosated derivatives, tamoxifen, staurosporine, β-estradiol, α-estradiol, estriol, estrone, ethinylestradiol, medroxyprogeste ron, estradiol cypionates, estradiol benzoates, tranilast, kamebakaurin and other terpenoids used in cancer therapy, verapamil, tyrosine kinase inhibitors (tyrphostins), paclitaxel and its derivatives such as 6-α-hydroxy paclitaxel, taxoters, carbon suboxide (MCS) and its macrocyclic oligomers, mofebutazone, lonazolac, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, sodium aurothiomalate, oxaceprol, β-sitosterol, myrtainaine, polidocanol, nonivamide, levomenthol, ellipticin, D-24851 (Calbiochem), colcemid, Cytochalasin AE, indanocine, nocadazole, S100 protein, bacitracin, vitronectin receptor antagonist, azelastine, guanidyl cyclase stimulator, metalloproteinase-1 and 2 tissue inhibitor, free nucleic acids, nucleic acids incorporated in virus carriers, DNA and RNA fragments, plaminogen activator inhibitor -1, plasminogen activator inhibitor-2, antisense oligonucleotides, VEGF inhibitors, IGF-1, drugs from the group ppe of antibiotics such as cefadroxil, cefazolin, cefaclor, Cefotixin tobramycin, gentamycin, penicillins such as dicloxacillin, oxacillin, sulfonamides, metronidazole, Enoxoparin, desulphated and N-reacetylated heparin (hemoparin ®), tissue plasminogen activator, GpIIb / IIIa platelet membrane receptor, Factor X a -Inhibitor Antibodies, heparin, hirudin, r-hirudin, PPACK, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators such as dipyramidol, trapidil, nitroprussides, PDGF antagonists such as triazolopyrimidine and seramin, ACE inhibitors such as captopril, cilazapril , Lisinopril, enalapril, losartan, thioprotease inhibitors, prostacyclin, vapiprost, interferon α, β and γ, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis regulators such as p65, NF-kB or Bcl-xL antisense oligonucleotides, halofuginone, nifedipine, tocopherol tranilast, molsidomine , Teepolyphenole, Epicatechin gallate, Epigallocatechin gallate, Leflunomide, Etanercept, Sulfasalazine, Etoposide, Diclox acyllin, tetracycline, triamcinolone, mutamycin, procainimide, retinoic acid, quinidine, disopyrimide, flecainide, propafenone, sotolol, natural and synthetic steroids such as inotodiol, maquiroside A, ghalakinoside, mansonine, strebloside, hydrocortisone, betamethasone, dexamethasone, nonsteroidal substances (NSAIDS) such as fenoporfen, ibuprofen, indomethacin, naproxen, phenylbutazone and other antiviral agents such as acyclovir, ganciclovir and zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprozoal agents such as chloroquine, mefloquine, quinine, and other natural terpenoids such as hippocaesculin , Barringtogenol-C21-angelate, 14-dehydroagrostistachine, agroskerin, agrostistachin, 17-hydroxyagrostistachine, ovatodiolides, 4,7-oxycycloanisomelic acid, baccharinoids B1, B2, B3 and B7, tubeimoside, bruceantinosides C, yadanziosides N, and P, isodeoxyelephantopin, tomenphantopin A and B, coronarine A, B, C and D, ursolic acid, hyptate acid A, iso- Iridogermanal. Maytenfoliol, Effusantin A, Excisanin A and B, Longikaurin B, Sculponeatin C, Kamebaunin, Leukamenin A and B, 13,18-Dehydro-6-alpha-Senecioyloxychaparrin, Taxamairin A and B, Regenilol, Triptolide, Cymarin, Hydroxyanopterin, Protoanemonin, cheliburine chloride, sinococulin A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxypregnadiene 3,20-dione, helenaline, indicin, indicin-N-oxide, lasiocarpine, inotodiol ,, podophyllotoxin, justicidin A and B, larreatin, malloterin, Mallotochromanol, Isobutyrylmallotochromanol, Maquiroside A, Marchantin A, Maytansin, Lycoridicin, Margetin, Pancratistatin, Liriodenin, Bispsrthenolidine, Oxoushinsunin, Periplocoside A, Ursolic Acid, Deoxypypsorospermine, Psycorubin, Ricin A, Sanguinarine, Manuwic Acid, Methylsorbifoline, Sphatheliachromes, Stizophyllin, Mansonine, Strebloside, Dihydrousambaraensin, Hydroxyusambarin, Strychnopentamine, Strychnophyllin, Usambarin, Usambarensin, Liriodenin, Oxoushinsunin, Daphnoretin, Lariciresinol, Methoxylariciresinol, Syringaresinol, Sirolimus (rapamycin), Somatostatin, Tacrolimus, Roxithromycin, Troleandomycin, Simvastatin, Rosuvastatin, Vinblastine, Vincristine, Vindesine, Teniposide, Vinorelbine, Tropfosfamide, Treosulfan, Tremozolomide, Thiotepa, Tretinoin, Spiramycin, Umbelliferone, Desacetylvismion A, Vismion A and B , Zeorin. Expandierbarer Ballon nach Anspruch 1 oder 2, wobei der antiproliferative, antiinflammatorische und/oder antimykotische Wirkstoff sich in und/oder unter einer Polymermatrix befindet.An expandable balloon according to claim 1 or 2, wherein the antiproliferative, anti-inflammatory and / or antifungal Active substance is located in and / or under a polymer matrix. Expandierbarer Ballon nach einem der vorherigen Ansprüche, wobei das oder die Polymere für die Polymermatrix aus der Gruppe ausgewählt werden umfassend: Polyvalerolactone, Poly-ε-Decalactone, Polylactonsäure, Polyglycolsäure Polylactide, Polyglycolide, Copolymere der Polylactide und Polyglycolide, Poly-ε-caprolacton, Polyhydroxybuttersäure, Polyhydroxybutyrate, Polyhydroxyvalerate, Polyhydroxybutyrate-co-valerate, Poly(1,4-dioxan-2,3-dione), Poly(1,3-dioxan-2-one), Poly-para-dioxanone, Polyanhydride, Polymaleinsäureanhydride, Polyhydroxymethacrylate, Fibrin, Polycyanoacrylate, Polycaprolactondimethylacrylate, Poly-β-Maleinsäure Polycaprolactonbutylacrylate, Multiblockpolymere aus Oligocaprolactondiole und Oligodioxanondiole, Polyetherestermultiblockpolymere aus PEG und Polybutylenterephtalat, Polypivotolactone, Polyglycolsäuretrimethylcarbonate Polycaprolactonglycolide, Poly(γ-ethylglutamat), Poly(DTH-Iminocarbonat), Poly(DTE-co-DT-carbonat), Poly(Bisphenol A-iminocarbonat), Polyorthoester, Polyglycolsäuretrimethylcarbonate, Polytrimethylcarbonate Polyiminocarbonate, Poly(N-vinyl)-Pyrrolidon, Polyvinylalkohole, Polyesteramide, glycolierte Polyester, Polyphosphoester, Polyphosphazene, Poly[p-carboxyphenoxy)propan], Polyhydroxypentansäure, Polyanhydride, Polyethylenoxidpropylenoxid, weiche Polyurethane, Polyurethane mit Aminosäurereste im Backbone, Polyetherester wie das Polyethylenoxid, Polyalkenoxalate, Polyorthoester sowie deren Copolymere, Lipide, Carrageenane, Fibrinogen, Stärke, Kollagen, proteinbasierende Polymere, Polyaminosäuren, synthetische Polyaminosäuren, Zein, Polyhydroxyalkanoate, Pectinsäure, Actinsäure, Carboxymethylsulfat, Albumin, Hyaluronsäure, Chitosan und seine Derivate, Heparansulfate und seine Derivate, Heparine, Chondroitinsulfat, Dextran, β-Cyclodextrine, Copolymere mit PEG und Polypropylenglycol, Gummi arabicum, Guar, Gelatine, Collagen Collagen-N-Hydroxysuccinimid, Lipide, Phospholipide, Polyacrylsäure, Polyacrylate, Polymethylmethacrylat, Polybutylmethacrylat, Polyacrylamid, Polyacrylonitrile, Polyamide, Polyetheramide, Polyethylenamin, Polyimide, Polycarbonate, Polycarbourethane, Polyvinylketone, Polyvinylhalogenide, Polyvinylidenhalogenide, Polyvinylether, Polyisobutylene, Polyvinylaromaten, Polyvinylester, Polyvinylpyrollidone, Polyoxymethylene, Polytetramethylenoxid, Polyethylen, Polypropylen, Polytetrafluorethylen, Polyurethane, Polyetherurethane, Silicon-Polyetherurethane, Silicon-Polyurethane, Silicon-Polycarbonat-Urethane, Polyolefin-Elastomere, Polyisobutylene, EPDM-Gummis, Fluorosilicone, Carboxymethylchitosane, Polyaryletheretherketone, Polyetheretherketone, Polyethylenterephtalat, Polyvalerate, Carboxymethylcellulose, Cellulose, Rayon, Rayontriacetate, Cellulosenitrate, Celluloseacetate, Hydroxyethylcellulose, Cellulosebutyrate, Celluloseacetatbutyrate, Ethylvinylacetat-copolymere, Polysulfone, Epoxyharze, ABS-Harze, EPDM-Gummis, Silicone wie Polysiloxane, Polydimethylsiloxane, Polyvinylhalogene und Copolymere, Celluloseether, Cellulosetriacetate, Chitosane und Copolymere und/oder Mischungen der vorgenannten Polymere.An expandable balloon according to any one of the preceding claims, wherein the polymer (s) for the polymer matrix are selected from the group comprising: polyvalerolactones, poly-ε-decalactones, polylactic acid, polyglycolic acid polylactides, polyglycolides, copolymers of polylactides and polyglycolides, poly-ε-caprolactone, Polyhydroxybutyric acid, polyhydroxybutyrates, polyhydroxyvalerates, polyhydroxybutyrate-co-valerates, poly (1,4-dioxane-2,3-diones), poly (1,3-dioxan-2-ones), poly-para-dioxanones, polyanhydrides, polymaleic anhydrides, Polyhydroxymethacrylates, fibrin, polycyanoacrylates, polycaprolactone dimethyl acrylates, poly-β-maleic acid, polycaprolactone butylacrylates, multiblock polymers of oligocaprolactone diols and oligodioxanonediols, polyetherester multiblock polymers of PEG and polybutylene terephthalate, polypivotolactones, polyglycolic acid trimethylcarbonates, polycaprolactone glycolides, poly (γ-ethylglutamate), poly (DTH-iminocarbonate), poly (DTE) co-DT-carbonate), poly (bisphenol A-iminocarbonate ), Polyorthoesters, polyglycolic acid trimethylcarbonates, polytrimethylcarbonates, polyiminocarbonates, poly (N-vinyl) pyrrolidone, polyvinyl alcohols, polyesteramides, glycolated polyesters, polyphosphoesters, polyphosphazenes, poly [p-carboxyphenoxy) propane], polyhydroxypentanoic acid, polyanhydrides, polyethylene oxide-propylene oxide, soft polyurethanes, polyure thane with amino acid residues in the backbone, polyether esters such as polyethylene oxide, polyalkene oxalates, polyorthoesters and their copolymers, lipids, carrageenans, fibrinogen, starch, collagen, protein-based polymers, polyamino acids, synthetic polyamino acids, zein, polyhydroxyalkanoates, pectinic acid, actinic acid, carboxymethylsulfate, albumin, hyaluronic acid, Chitosan and its derivatives, heparan sulphates and its derivatives, heparins, chondroitin sulphate, dextran, β-cyclodextrins, copolymers with PEG and polypropylene glycol, gum arabic, guar, gelatine, collagen collagen N-hydroxysuccinimide, lipids, phospholipids, polyacrylic acid, polyacrylates, polymethylmethacrylate, Polybutyl methacrylate, polyacrylamide, polyacrylonitriles, polyamides, polyetheramides, polyethyleneamine, polyimides, polycarbonates, polycarbourethanes, polyvinyl ketones, polyvinyl halides, polyvinylidene halides, polyvinyl ethers, polyisobutylenes, polyvinylaromatics, polyvinyl esters, polyvinylpyrollidones, polyoxymethylenes, polyt etramethylene oxide, polyethylene, polypropylene, polytetrafluoroethylene, polyurethanes, polyether urethanes, silicone polyether urethanes, silicone polyurethanes, silicone polycarbonate urethanes, polyolefin elastomers, polyisobutylenes, EPDM rubbers, fluorosilicones, carboxymethyl chitosans, polyaryletheretherketones, polyetheretherketones, polyethylene terephthalate, polyvalerates, carboxymethylcellulose, Cellulose, rayon, rayon triacetates, cellulose nitrates, cellulose acetates, hydroxyethylcellulose, cellulose butyrates, cellulose acetate butyrates, ethylvinylacetate copolymers, polysulphones, epoxy resins, ABS resins, EPDM rubbers, silicones such as polysiloxanes, polydimethylsiloxanes, polyvinylhalogens and copolymers, cellulose ethers, cellulose triacetates, chitosans and copolymers and / or mixtures of the aforementioned polymers. Expandierbarer Ballon nach einem der vorherigen Ansprüche, wobei die Schicht umfassend mindestens einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff gleichzeitig auf den Ballon und den Stent aufgetragen worden ist.Expandable balloon according to one of the preceding claims, wherein the layer comprising at least one antiproliferative, anti-inflammatory and / or antifungal agent simultaneously on the balloon and the stent has been applied. Expandierbarer Ballon nach einem der vorherigen Ansprüche, wobei sich unter und/oder auf der mindestens einen antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff enthaltenden Schicht noch eine weitere biostabile oder bioabbaubare Schicht befindet.Expandable balloon according to one of the preceding claims, wherein under and / or on the at least one antiproliferative, anti-inflammatory and / or antifungal agent Layer yet another biostable or biodegradable layer is located. Verfahren zur Beschichtung eines expandierbaren Ballons mit aufgesetztem Stent mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff umfassend die folgenden Schritte: a) Bereitstellen eines Ballons für einen Dilatationskatheter, b) Aufsetzen eines nichtexpandierten Stent, c) gleichzeitige Beschichtung von Ballon und Stent mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff.Process for coating an expandable balloon with attached stent with at least one antiproliferative, comprising antiinflammatory and / or antifungal agent the following steps: a) providing a balloon for a dilatation catheter b) placing a non-expanded stent, c) simultaneous coating of balloon and stent with at least one antiproliferative, anti-inflammatory and / or antifungal Active ingredient. Verfahren zur Beschichtung nach Anspruch 7, des weitern umfassend den Schritt b') und/oder d') Aufbringen einer biostabilen und/oder bioabbaubaren Schicht.A method of coating according to claim 7, further comprising step b ') and / or d ') application a biostable and / or biodegradable layer. Mit mindestens einem antiproliferativen, antiinflammatorischen und/oder antimykotischen Wirkstoff beschichteter expandierbarer Ballon mit aufgesetztem Stent erhältlich nach einem Verfahren gemäß Anspruch 8 oder 9.With at least one antiproliferative, anti-inflammatory and / or antifungal agent coated expandable Balloon with attached stent available by a method according to claim 8 or 9. Expandierbarer Ballon mit aufgesetztem Stent für die Verwendung zur Verhinderung oder Reduzierung von Restenose.Expandable balloon with attached stent for use to prevent or reduce restenosis.
DE200410046244 2004-09-22 2004-09-22 Expandable balloon mounted on stent, useful for the prevention or reduction of restenosis, comprises a coating of at least antiproliferative, antiinflammatory and/or antimycotic active substance on both stent and balloon Withdrawn DE102004046244A1 (en)

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