FDA批准PerQseal Elite血管闭合系统：无缝线封堵大口径动脉穿刺口 临床试验主要并发症为零
Boston 消息：医疗科技公司 Haemonetics（纽约证券交易所代码：HAE）10月19日宣布，美国食品药品监管局 FDA 已批准其 PerQseal Elite 血管闭合系统用于大口径动脉手术的血管闭合。该公司今年1月完成对 Vivasure Medical 的收购后，将这一产品纳入其结构性心脏与血管内手术闭合器械组合。
PerQseal Elite 为无缝线闭合设计，适用于使用 14 至 22F 鞘管的结构性心脏与血管内手术：其全生物可吸收贴片从血管内部封堵最大 26F 的动脉切口，可实现接近即时的止血，且不留下永久植入物。医生在最终释放植入物之前，可以在保持导丝通路的同时确认止血效果，并可调整位置或回收系统。
支持此次批准的前瞻性、单臂、多中心 ELITE 动脉研究结果显示，按 VARC-3 标准统计的主要并发症发生率为 0%，平均止血时间不到一分钟。该产品已于 2025 年在欧洲获得 CE 标志，涵盖动脉与静脉适应症。
Haemonetics 高级副总裁兼首席医疗官 Jan Hartmann 表示，FDA 批准是该公司加强其在先进血管闭合领域布局的重要一步，这项贴片式闭合方案有望进一步简化经导管主动脉瓣置换（TAVR）等微创手术，并改善患者体验。（GSM 据 Haemonetics 公司经 PR Newswire 发布的公告）
FDA Approves PerQseal Elite Vascular Closure System: Sutureless Large-Bore Closure With Zero Major Complications in Trial
Boston: Haemonetics Corporation (NYSE: HAE) announced on October 19 that the U.S. Food and Drug Administration (FDA) has approved its PerQseal Elite vascular closure system for large-bore arterial procedures. The approval expands the company's portfolio of closure devices for structural heart and endovascular procedures in the United States, following its acquisition of Vivasure Medical Limited in January 2026.
PerQseal Elite provides sutureless, large-bore vascular closure following structural heart and endovascular procedures performed with 14 to 22F sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26F from within the vessel, enabling near-instantaneous hemostasis and leaving nothing permanent behind. Physicians can confirm hemostasis while maintaining guidewire access, with the flexibility to reposition or recover the system until implant release.
Results from the prospective, single-arm, multicenter ELITE arterial study demonstrated 0% major complications per VARC-3 criteria and a mean time to hemostasis of less than one minute. PerQseal Elite received CE Mark approval in Europe in 2025 for both arterial and venous indications.
Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics, said the FDA approval is an important milestone in the company's strategy to bolster its presence in advanced vascular closure, and that the patch-based approach has the potential to further simplify minimally invasive procedures such as TAVR while supporting patient comfort and experience. (GSM, from Haemonetics' announcement via PR Newswire)
发布：GSM·美国（发布链接）
图片来源：图：心导管手术室资料图，医护人员在手术中操作导管器械。美国海军医学中心 San Diego 官方照片，公有领域，取自 Wikimedia Commons。Photo: Cardiac catheterization procedure (file photo). U.S. Navy photo, Naval Medical Center San Diego, public domain, via Wikimedia Commons.
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