Vivasure Medical has 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 implantation (TAVI) 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 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 utilising 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.
