Vivasure Medical has submitted its PerQSeal Elite vascular closure system for premarket approval (PMA) to the U.S. FDA, marking a significant milestone for the Galway, Ireland-based medtech company. The system, designed for percutaneous vessel closure, builds on the proven performance of the original PerQSeal with faster delivery and improved usability, especially in cases involving calcium or large-hole venous access—such as transcatheter mitral and aortic valve procedures (TMVR/TAVR).
PerQSeal Elite is touted as the first fully absorbable, sutureless implant for large-bore vascular closure, deployed from within the vessel itself. This inside-out approach simplifies placement and enhances procedural control compared to conventional techniques. According to Vivasure, no other bioresorbable closure devices currently exist for large-bore applications.
The FDA submission follows encouraging data from the PATCH study and strong clinical uptake in Europe. Vivasure received CE mark approval in April and has since expanded the device’s European indications to include large-bore venous closure.
“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.”
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