Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).
Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. The system leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. It aims to improve performance in calcium and the treatment of large-hole venous procedures, according to the company. That includes transcatheter mitral and aortic valve repair and replacement (TMVR/TAVR).
Vivasure labeled PerQseal the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Placement occurs from inside the vessel. It makes deployment simpler and more controlled than conventional closure techniques. Additionally, the company says there are no fully bioresorbable devices available for closure following large-bore procedures.
Related: Exo lands FDA clearance for two AI lung disease ultrasound apps
The submission follows positive clinical results from the PATCH study, plus strong early feedback from clinical use in Europe. Vivasure won CE mark for the device in April and, in addition to its PMA submission, expanded its indication to cover large-bore venous closure there.
“We are proud to advance PerQseal Elite through these two key regulatory milestones as part of our commitment to delivering next-generation technologies for large-bore vascular closure,” said Andrew Glass, CEO of Vivasure Medical. “Achieving CE mark expansion for venous indications and submitting our PMA application are important steps toward making our fully absorbable, sutureless solution more broadly accessible, while continuing to build a strong foundation for global commercial growth.”
