FDA Approves Large-Bore Closure System for Structural Heart and Endovascular Procedures

The FDA has approved the PerQseal Elite vascular closure system (Haemonetics) for large-bore arterial procedures, the company announced in a press release.

According to the company, the sutureless system is designed for large-bore vascular closure following structural heart and endovascular procedures performed with 14F to 22F sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26F from within the vessel. Physicians can confirm hemostasis while maintaining guidewire access and can reposition or recover the system until the implant is released, the company said.

In the prospective, single-arm, multicenter ELITE arterial study, the company reported no VARC-3 major device-related vascular access site complications through 30 days and a mean time to hemostasis of less than 1 minute. The announcement did not report the number of patients enrolled.

PerQseal Elite received CE Mark approval in Europe in 2025 for both arterial and venous indications; the US approval announced by Haemonetics covers large-bore arterial procedures. The company said the approval expands its large-bore closure portfolio for structural heart and endovascular procedures, following its acquisition of Vivasure Medical Limited in January 2026. Jan Hartmann, MD, chief medical officer at Haemonetics, said the device has the potential to further simplify minimally invasive procedures such as TAVR.

Haemonetics said clinical data on the system will be presented at the Transcatheter Cardiovascular Therapeutics Conference at the end of October.

Source: Haemonetics. Haemonetics announces FDA approval of PerQseal Elite vascular closure system. Press release. Haemonetics; October 19, 2026. Accessed October 21, 2026.