FDA Approves Bioabsorbable Patch Technology for Large-Bore Vascular Closure

Closure systems must achieve hemostasis while integrating efficiently into procedural workflows. Addressing these requirements, a newly approved vascular closure system now offers a sutureless, patch-based option for large-bore arterial procedures.

Haemonetics Corporation (Boston, MA, USA) has received U.S. Food and Drug Administration (FDA) approval for the PerQseal Elite vascular closure system. The system is indicated for large-bore arterial procedures. The approval expands Haemonetics’ portfolio of large-bore closure devices for structural heart and endovascular procedures in the U.S. after its acquisition of Vivasure Medical Limited in January 2026.

PerQseal Elite provides sutureless, large-bore vascular closure after structural heart and endovascular procedures performed with 14–22F sheaths. The system uses a fully bioabsorbable patch that seals arteriotomies up to 26F from within the vessel. It is designed to enable near-instantaneous hemostasis while leaving nothing permanent behind. Physicians can confirm hemostasis while maintaining guidewire access, with the flexibility to reposition or recover the system until implant release.

In the prospective, single-arm, multicenter ELITE arterial study, results showed 0% major complications per VARC-3 and a mean time to hemostasis of less than one minute. The complication measure covered major device-related vascular access site complications through 30 days. PerQseal Elite received CE Mark approval in Europe in 2025 for both arterial and venous indications, and clinical data related to the system will be presented and discussed by Haemonetics at the Transcatheter Cardiovascular Therapeutics (TCT) Conference at the end of October.

“FDA approval represents an important milestone in our strategy to bolster our presence and growth in advanced vascular closure, with new and meaningful innovation to meet evolving procedural needs. PerQseal Elite has the potential to further simplify minimally invasive procedures such as TAVR, while supporting patient comfort and experience. We are pleased to offer physicians and their patients in the U.S. this novel, patch-based approach to large-bore vascular closure,” said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics.

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