Abbott的Amplatzer Paraclose瓣周漏封堵器获FDA批准 成美国首款专治瓣周漏的微创器械
Abbott Park——医疗企业 Abbott（雅培）10月28日宣布，其 Amplatzer Paraclose 瓣周漏封堵器已获美国食品药品监管局（FDA）批准，成为美国首款、也是唯一一款专门为治疗瓣周漏（PVL）设计的经导管器械，患者无须再接受一次开胸手术即可封堵漏口。
瓣周漏指置换后的心脏瓣膜与自身组织之间留有或后来形成缝隙、血液从缝隙回流的现象。Abbott 称，这类泄漏见于7%至17%的二尖瓣置换和5%至10%的主动脉瓣置换，可引发气短、乏力、腿脚肿胀等心力衰竭症状，还可造成红细胞受损的溶血、进而导致严重贫血。Paraclose 经腿部动脉或静脉送入导管植入，器械呈椭圆形设计，可贴合不同形状与大小的漏口。
此次批准得到 PARADIGM 研究数据的支持：这是一项前瞻性、多中心、单臂研究，共纳入200名患者，结果显示 Paraclose 可提供有效的微创方案、替代再次开胸手术。Cleveland Clinic 心血管医学部的 Amar Krishnaswarmy 说，美国批准 Paraclose 填补了瓣周漏治疗的一大空白，其椭圆形状专为封堵各种形状与大小的瓣周漏而设计，让许多患者免于再次心脏手术。
Abbott 结构性心脏业务高级副总裁 Sandra Lesenfants 表示，此前美国医生治疗瓣周漏没有已获批准的替代方案，只能再次开胸，Paraclose 这一专门设计的器械填补了这一未被满足的需求。该器械在美国以外以 Amplatzer Valvular Plug III 之名销售，自2020年起已在欧洲获批用于治疗瓣周漏。
FDA Approves Abbott's Amplatzer Paraclose, the First U.S. Transcatheter Device Designed to Treat Paravalvular Leak
Abbott Park, Illinois — Abbott announced on October 28 that the U.S. Food and Drug Administration (FDA) has approved its Amplatzer Paraclose PVL Occluder, the first and only transcatheter device approved in the U.S. specifically designed to treat paravalvular leak (PVL), a backflow of blood around a surgical heart valve, giving patients a minimally invasive option instead of another open-heart surgery.
A paravalvular leak occurs when a small gap remains or develops over time between native heart tissue and a replacement valve. Abbott says such leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements, and can lead to heart-failure symptoms including shortness of breath, fatigue and swelling of the legs and feet, as well as hemolysis, in which red blood cells are damaged, causing severe anemia. The Paraclose device is implanted through a catheter inserted through an artery or vein in the leg, and its oblong, elliptical shape is designed to close a wide range of leak shapes and sizes.
The approval was supported by data from the PARADIGM study, a prospective, multicenter, single-arm study of 200 patients, which Abbott said demonstrated that Paraclose provides an effective, minimally invasive alternative to open-heart reoperation. Amar Krishnaswarmy, M.D., section head of Invasive & Interventional Cardiology at the Cleveland Clinic, said the U.S. approval addresses a significant treatment gap for people suffering from a paravalvular leak and lets many patients avoid another cardiac surgery.
Sandra Lesenfants, senior vice president of Abbott's structural heart business, said physicians treating PVL in the U.S. previously did not have an approved alternative to repeat open-heart surgery, and that the purpose-built device fills a critical unmet need. Outside the U.S., the device is known as the Amplatzer Valvular Plug III and has been approved to treat PVL in Europe since 2020.
来源：GSM·美国（原文链接）
图片来源：图：Abbott（雅培）公司标志。本图为该公司标志图，公共领域版本，经 Wikimedia Commons。 / Abbott Laboratories logo (public domain version, via Wikimedia Commons).
