Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. It leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. The system improves performance in calcium and the treatment of large-hole venous procedures, according to the company. That includes transcatheter mitral and aortic valve repair and replacement (TMVR/TAVR).
Vivasure says PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Placement occurs from inside the vessel. It makes deployment simpler and more controlled than conventional closure techniques. With no pre-procedure step, the device further separates it from other current devices. Additionally, the company says there are no fully bioresorbable devices available for closure following large-bore procedures.
With CE mark in hand, Vivasure plans to begin a launch for PerQseal Elite in select European markets this summer.
“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.”
