FDA Approves Haemonetics PerQseal Elite Vascular Closure System

October 20, 2026—Haemonetics Corporation announced FDA approval of the PerQseal Elite vascular closure system for large-bore arterial procedures.

According to Haemonetics, the approval expands its portfolio of large-bore closure devices for structural heart and endovascular procedures in the United States after the company’s acquisition of Vivasure Medical Limited announced in January 2026.

The company stated that the PerQseal Elite system provides sutureless, large-bore vascular closure after structural heart and endovascular procedures performed with 14- to 22-F sheaths. The device’s fully bioabsorbable patch seals arteriotomies up to 26 F from within the vessel, enabling near-instantaneous hemostasis and leaving nothing permanent behind.

Results from the prospective, single-arm, multicenter ELITE arterial study demonstrated 0% major complications per Valve Academic Research Consortium-3 and a mean time to hemostasis of < 1 minute.

In 2025, PerQseal Elite received CE Mark approval in Europe for both arterial and venous indications.

Professor Nicolas van Mieghem, MD, who is coinvestigator of the ELITE study clinical trials and interventional cardiologist at ZOL Hospital in Genk, Belgium, commented on the device in the company’s press release.

“I have found PerQseal Elite to be easy to adopt and intuitive to use, with rapid hemostasis being a particularly notable feature,” stated Prof. van Mieghem. “In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions.”

Haemonetics advised it will present and discuss clinical data related to PerQseal Elite at TCT 2026, the Transcatheter Cardiovascular Therapeutics scientific symposium to be held from October 31 to November 3.