Haemonetics Wins FDA Approval for PerQseal Elite Vascular Closure System

Haemonetics Corp. (HAE) said the U.S. Food and Drug Administration approved its PerQseal Elite vascular closure system for large-bore arterial procedures, expanding the company's U.S. structural heart and endovascular portfolio following its Vivasure acquisition. The sutureless device uses a fully bioabsorbable patch to seal vessel access sites from within the artery, enabling rapid hemostasis without leaving a permanent implant. It allows physicians to confirm closure while maintaining guidewire access, with the option to reposition or retrieve the device before final deployment. In the multicenter ELITE study, it showed 0% major VARC-3 complications and a mean time to hemostasis under one minute. PerQseal Elite received CE Mark approval in Europe in 2025 for arterial and venous applications. Haemonetics will present clinical data on the device at the Transcatheter Cardiovascular Therapeutics Conference at the end of October. HAE closed Monday's trade at $118.73, up 0.38%, and rose 2.45% to $121.64 in overnight trading.