Vivasure Submits PerQseal Elite to FDA; Earns CE Mark for Expanded Indication

Vivasure Medical announced it has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures.

This submission follows the successful results of the company’s PATCH study and positive clinical use in Europe, which reinforced PerQseal Elite’s potential safety and performance profile. Vivasure also received CE mark approval for an expanded indication covering large-bore venous closure. This followed its first CE mark approval in April for arterial procedures and positions the technology as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.

PerQseal Elite was designed for fully absorbable, sutureless closure following percutaneous cardiovascular procedures. There aren’t currently any fully bioabsorbable devices on the market for closure after large-bore procedures. Further, PerQseal Elite doesn’t need any pre-procedure steps, according to Vivasure.

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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.

“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, MD, section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System in New York City. “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.”

“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.”