Vivasure Medical has announced the submission of a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures.
The submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile.
In addition, the company received European CE mark approval for an expanded indication for PerQseal Elite covering large-bore venous closure. This follows its first CE mark approval in April 2025 for arterial procedures and positions PerQseal Elite as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.
“With the increasing adoption of minimally invasive therapies in structural heart and electrophysiology procedures, managing large-bore access sites remains a critical consideration,” said Azeem Latib (Montefiore Health System, New York, USA). “PerQseal Elite was designed to address the growing need with a novel, fully bioabsorbable approach and we look forward to further progress in the program.”
The PerQseal Elite vascular closure system is designed for fully absorbable, sutureless closure following percutaneous cardiovascular procedures. Currently, there are no fully bioresorbable devices available on the market for closure following large-bore procedures.
“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.”
The PerQseal Elite vascular closure system is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques and returning the vessel to its natural state without leaving materials like collagen, metal implants, or sutures behind, Vivasure Medical details in a press release.
