Vivasure Medical Submits PMA Application for PerQseal® Elite and Secures Expanded Venous Indication in Europe
Regulatory progress underscores global momentum for PerQseal Elite in transforming large-bore vascular closure
Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the submission of a Premarket Approval (PMA) application to the U.S. 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, M.D., 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."
Leveraging Vivasure's PerQseal technology, 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. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure steps, further simplifying the process.
"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.
About Vivasure Medical
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.
In 2023, Vivasure Medical received a €30 million strategic investment from Haemonetics Corporation (NYSE:HAE), in an agreement which includes an option to acquire Vivasure Medical upon completion of certain milestones. The company is also backed by Fountain Healthcare Partners, Orchestra BioMed Holdings Inc. (NASDAQ:OBIO), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners, and Evonik Venture Capital. In addition, Vivasure Medical has received support from Enterprise Ireland and the European Investment Bank.
The PerQseal® and PerQseal® Elite are not available for sale in the United States.
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