Vivasure Medical Receives CE Mark Approval in Europe for PerQseal Elite Vascular Closure System

First fully absorbable, sutureless closure system designed for large-bore procedures aims to improve procedural efficiency and patient outcomes in structural heart interventions

GALWAY, Ireland--(BUSINESS WIRE)-- Vivasure Medical^®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced European CE mark approval of the PerQseal^® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The company plans to launch the product in select European markets this summer.

Leveraging Vivasure’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore closure following percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR) and Endovascular Aortic Repair (EVAR). Currently, there are no fully bioresorbable devices available for closure following large-bore procedures. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure step, further simplifying the procedure.

“Vascular closure remains a challenge for the growing cardiovascular procedures that require large bore access. The introduction of PerQseal Elite is an exciting advancement for large-bore cardiovascular procedures,” said Dr. Mohamed Abdel-Wahab, Professor of Interventional Cardiology and Head of Structural Heart Disease Department at the Heart Center in Leipzig, Germany. “Having a fully absorbable, sutureless closure option simplifies the procedure and has the potential to reduce complications associated with traditional closure methods. We look forward to utilizing this technology to treat our patients.”

“Securing CE Mark approval for PerQseal Elite marks a major milestone for Vivasure and for patients undergoing complex structural heart procedures,” said Andrew Glass, CEO of Vivasure Medical. “PerQseal Elite represents a significant advancement in procedural efficiency and patient care. We’re proud to bring this innovative technology to clinicians across Europe.”

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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Jenna Kane

Health+Commerce

jennakane@healthandcommerce.com

Source: Vivasure Medical