CA3191028A1 - Prosthetic valves for implantation - Google Patents

Prosthetic valves for implantation

Info

Publication number
CA3191028A1
CA3191028A1 CA3191028A CA3191028A CA3191028A1 CA 3191028 A1 CA3191028 A1 CA 3191028A1 CA 3191028 A CA3191028 A CA 3191028A CA 3191028 A CA3191028 A CA 3191028A CA 3191028 A1 CA3191028 A1 CA 3191028A1
Authority
CA
Canada
Prior art keywords
prosthetic valve
valve
anchors
frame
native
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3191028A
Other languages
English (en)
French (fr)
Inventor
Matthew A. Peterson
Siddharth Vad
Scott Louis SHARY
Taylor Jacob Scheinblum
Kevin M. Golemo
Yevgeniy Davidovich KAUFMAN
David Robert Landon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of CA3191028A1 publication Critical patent/CA3191028A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/0069—Sealing means
    • 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
    • A61F2250/0069—Sealing means
    • A61F2250/007—O-rings

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
CA3191028A 2020-08-28 2021-08-20 Prosthetic valves for implantation Pending CA3191028A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202063071684P 2020-08-28 2020-08-28
US63/071,684 2020-08-28
US202063199267P 2020-12-16 2020-12-16
US63/199,267 2020-12-16
PCT/US2021/047000 WO2022046568A1 (en) 2020-08-28 2021-08-20 Prosthetic valves for implantation

Publications (1)

Publication Number Publication Date
CA3191028A1 true CA3191028A1 (en) 2022-03-03

Family

ID=77739147

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3191028A Pending CA3191028A1 (en) 2020-08-28 2021-08-20 Prosthetic valves for implantation

Country Status (6)

Country Link
US (2) US20230200980A1 (enExample)
EP (1) EP4175593A1 (enExample)
JP (1) JP2023540065A (enExample)
CN (1) CN116171142A (enExample)
CA (1) CA3191028A1 (enExample)
WO (1) WO2022046568A1 (enExample)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008513060A (ja) 2004-09-14 2008-05-01 エドワーズ ライフサイエンシーズ アーゲー 心臓弁逆流の処置のためのデバイスおよび方法
US20090276040A1 (en) 2008-05-01 2009-11-05 Edwards Lifesciences Corporation Device and method for replacing mitral valve
WO2010057262A1 (en) 2008-11-21 2010-05-27 Percutaneous Cardiovascular Solutions Pty Limited Heart valve prosthesis and method
EP4119098A1 (en) 2009-04-15 2023-01-18 Edwards Lifesciences CardiAQ LLC Vascular implant and delivery system
CA2760461C (en) 2009-04-29 2014-10-07 The Cleveland Clinic Foundation Apparatus and method for replacing a diseased cardiac valve
US8449599B2 (en) 2009-12-04 2013-05-28 Edwards Lifesciences Corporation Prosthetic valve for replacing mitral valve
US8579964B2 (en) 2010-05-05 2013-11-12 Neovasc Inc. Transcatheter mitral valve prosthesis
US11653910B2 (en) 2010-07-21 2023-05-23 Cardiovalve Ltd. Helical anchor implantation
WO2012040655A2 (en) 2010-09-23 2012-03-29 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
US12502276B2 (en) 2011-05-16 2025-12-23 Edwards Lifesciences Corporation Inversion delivery device and method for a prosthesis
US9439763B2 (en) 2013-02-04 2016-09-13 Edwards Lifesciences Corporation Prosthetic valve for replacing mitral valve
US20140277427A1 (en) 2013-03-14 2014-09-18 Cardiaq Valve Technologies, Inc. Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
WO2015127283A1 (en) 2014-02-21 2015-08-27 Cardiaq Valve Technologies, Inc. Delivery device for controlled deployement of a replacement valve
US9532870B2 (en) 2014-06-06 2017-01-03 Edwards Lifesciences Corporation Prosthetic valve for replacing a mitral valve
EP3174502B1 (en) 2014-07-30 2022-04-06 Cardiovalve Ltd Apparatus for implantation of an articulatable prosthetic valve
BR112017006248A2 (pt) 2014-09-28 2017-12-12 Cardiokinetix Inc aparelhos para o tratamento de insuficiência cardíaca
US10531951B2 (en) 2014-11-26 2020-01-14 Edwards Lifesciences Corporation Transcatheter prosthetic heart valve and delivery system
EP3253333B1 (en) 2015-02-05 2024-04-03 Cardiovalve Ltd Prosthetic valve with axially-sliding frames
WO2016153918A1 (en) 2015-03-20 2016-09-29 Cardiokinetix, Inc. Systems and methods for delivering an implantable device
US10441416B2 (en) 2015-04-21 2019-10-15 Edwards Lifesciences Corporation Percutaneous mitral valve replacement device
US10531866B2 (en) 2016-02-16 2020-01-14 Cardiovalve Ltd. Techniques for providing a replacement valve and transseptal communication
US10350062B2 (en) 2016-07-21 2019-07-16 Edwards Lifesciences Corporation Replacement heart valve prosthesis
US20190231525A1 (en) 2016-08-01 2019-08-01 Mitraltech Ltd. Minimally-invasive delivery systems
US10639143B2 (en) 2016-08-26 2020-05-05 Edwards Lifesciences Corporation Multi-portion replacement heart valve prosthesis
EP3648708A4 (en) 2017-07-06 2021-03-31 Edwards Lifesciences Corporation CONTROLLED DISPENSING SYSTEM AND COMPONENTS
US11793633B2 (en) 2017-08-03 2023-10-24 Cardiovalve Ltd. Prosthetic heart valve
US12064347B2 (en) 2017-08-03 2024-08-20 Cardiovalve Ltd. Prosthetic heart valve
US11337802B2 (en) 2017-09-19 2022-05-24 Cardiovalve Ltd. Heart valve delivery systems and methods
US12458493B2 (en) 2017-09-19 2025-11-04 Cardiovalve Ltd. Prosthetic heart valve and delivery systems and methods
EP3720390B1 (en) 2018-01-25 2024-05-01 Edwards Lifesciences Corporation Delivery system for aided replacement valve recapture and repositioning post- deployment
US12121436B2 (en) * 2018-12-04 2024-10-22 Medtronic Bakken Research Center B.V. Prosthetic heart valve
EP3921012A1 (en) 2019-02-04 2021-12-15 Edwards Lifesciences Corporation Guide wire apparatuses and methods
GB201901887D0 (en) 2019-02-11 2019-04-03 Cardiovalve Ltd Device for conditioning ex vivo pericardial tissue
EP3952790A1 (en) 2019-04-12 2022-02-16 W.L. Gore & Associates, Inc. Valve with multi-part frame and associated resilient bridging features
ES2982566T3 (es) 2019-04-23 2024-10-16 Edwards Lifesciences Corp Sistema de suministro de implantes motorizado
EP3881801B1 (en) * 2020-03-18 2025-04-23 Medtronic Inc. Improvements in or relating to the delivery and unsheathing of prosthetic heart valves
US12357459B2 (en) 2020-12-03 2025-07-15 Cardiovalve Ltd. Transluminal delivery system
WO2022132569A1 (en) 2020-12-18 2022-06-23 Edwards Lifesciences Corporation Storage jar assembly for aprosthetic heart valve
KR102918984B1 (ko) 2021-10-27 2026-01-28 에드워즈 라이프사이언시스 코포레이션 인공 심장 판막의 클림핑 및 로딩을 위한 시스템 및 방법
WO2023238130A1 (en) * 2022-06-08 2023-12-14 Cardiovalve Ltd. Implant with shape-conforming element
JP2026502970A (ja) * 2022-12-29 2026-01-27 エドワーズ ライフサイエンシーズ コーポレイション 人工弁用の送達システムおよびテザーアセンブリー
CN116869708B (zh) * 2023-08-17 2024-08-09 上海傲流医疗科技有限公司 一种瓣膜置换装置

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10441416B2 (en) * 2015-04-21 2019-10-15 Edwards Lifesciences Corporation Percutaneous mitral valve replacement device
US10172710B2 (en) * 2016-05-10 2019-01-08 William Joseph Drasler Two component mitral valve
US10639143B2 (en) * 2016-08-26 2020-05-05 Edwards Lifesciences Corporation Multi-portion replacement heart valve prosthesis

Also Published As

Publication number Publication date
EP4175593A1 (en) 2023-05-10
US20260083551A1 (en) 2026-03-26
CN116171142A (zh) 2023-05-26
US20230200980A1 (en) 2023-06-29
WO2022046568A1 (en) 2022-03-03
JP2023540065A (ja) 2023-09-21

Similar Documents

Publication Publication Date Title
CA3191028A1 (en) Prosthetic valves for implantation
US20230390052A1 (en) Prosthetic valve systems, components, and methods
US20250107889A1 (en) Prosthetic valves for implantation in calcified native valves
US20230157814A1 (en) Multi-portion replacement heart valve prosthesis
US20250099232A1 (en) Prosthetic valves for deployment
US11376119B2 (en) Vascular implant and delivery system
US8961593B2 (en) Prosthetic heart valve systems
US10034750B2 (en) Prosthetic heart valve devices and associated systems and methods
EP2575681B1 (en) Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
AU2012325809B2 (en) Devices, systems and methods for heart valve replacement
US20150351903A1 (en) Devices, systems and methods for heart valve replacement
CN106999273A (zh) 具有无支撑瓣膜区段的分段式经导管瓣膜假体
CN103974674A (zh) 人工心脏瓣膜装置、人工二尖瓣和相关系统及方法
US20250312150A1 (en) Systems, apparatuses, and methods for prosthetic valves
CN119326554A (zh) 瓣膜支架、瓣膜假体及用于制备医疗器械的用途
US20260076797A1 (en) Transcatheter heart valves with improved blood flow

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240722

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240722

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250702

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250702

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D11-D117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION RECEIVED

Effective date: 20250819

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P11-P101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - VOLUNTARY AMENDMENT

Effective date: 20250819

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250819

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250902

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251029

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-D155 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALL REQUIREMENTS FOR EXAMINATION DETERMINED COMPLIANT

Effective date: 20251029

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20251029

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20251029

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20251104