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)
Published by GSM · USA (original Chinese edition)
Photo: 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.
