Haemonetics has announced US Food and Drug Administration (FDA) approval of the PerQseal Elite vascular closure system for large-bore arterial procedures.
According to the company, the approval expands Haemonetics’ portfolio of clinically-differentiated large-bore closure devices for structural heart and endovascular procedures in the USA, following its acquisition of Vivasure Medical in January 2026.
Haemonetics shares that the PerQseal Elite system provides sutureless, large-bore vascular closure following structural heart and endovascular procedures performed with 14–22Fr sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26Fr from within the vessel, enabling near-instantaneous haemostasis and leaving nothing permanent behind. Physicians can confirm haemostasis while maintaining guidewire access, with the flexibility to reposition or recover the system until implant release.
Results from the prospective, single-arm, multicentre ELITE arterial study demonstrated 0% major complications per VARC-3 and a mean time to haemostasis of less than one minute. In 2025, PerQseal Elite received CE mark approval in Europe for both arterial and venous indications.
“US 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,” said Jan Hartmann, senior vice president and chief medical officer at Haemonetics. “PerQseal Elite has the potential to further simplify minimally invasive procedures such as transcatheter aortic valve replacement (TAVR), while supporting patient comfort and experience. We are pleased to offer physicians and their patients in the US this novel, patch-based approach to large-bore vascular closure.”
Nicolas van Mieghem, co-investigator of the ELITE study clinical trials and interventional cardiologist at ZOL Hospital in Genk, Belgium, said: “I have found PerQseal Elite to be easy to adopt and intuitive to use, with rapid haemostasis being a particularly notable feature. In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions.”
Clinical data related to PerQseal Elite will be presented and discussed by Haemonetics at the Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–3 November, San Diego, USA).
