Vivasure Medical has received CE mark approval for its PerQseal Elite, a next-generation vascular closure system designed for percutaneous large-bore vessel closure. Building on its predecessor’s strong safety and ease of use, PerQseal Elite enables faster, more controlled deployment, especially in challenging cases involving calcified vessels and large-hole venous procedures such as transcatheter mitral and aortic valve repair/replacement (TMVR/TAVR).
Uniquely, PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore punctures, placed from inside the vessel, simplifying closure without pre-procedure steps. Vivasure highlights that no fully bioresorbable closure devices currently exist for large-bore interventions.
With CE mark approval, Vivasure plans a European launch of PerQseal Elite this summer.
Andrew Glass, CEO, called this a major milestone that advances procedural efficiency and patient care in complex structural heart interventions.
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