Vivasure Medical reported positive data from an FDA investigational device exemption (IDE) pivotal study evaluating its PerQseal closure device system.
Initial results came from the PATCH pivotal study evaluating the safety and efficacy of PerQseal. Investigators presented findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.
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 new system also improves performance in calcium and the treatment of large-hole venous procedures. That includes transcatheter mitral and aortic valve repair and replacement (TMVR/TAVR).
The company says PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Placement occurs from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.
Vivasure’s PATCH study enrolled 145 patients across 17 U.S. and European investigational sites. It evaluated PerQseal when used to achieve hemostasis of common femoral arteriotomies created by 12 to 22F sheaths (arteriotomies up to 26F) in subjects undergoing percutaneous catheter-based interventional procedures.
Data demonstrated a low 0.8% Valve Academic Research Consortium 3 (VARC-3) major complication rate at discharge in 124 patients included in the study’s primary intention-to-treat analysis. Times to hemostasis following percutaneous procedures were rapid, with a median time of zero minutes.
“We are addressing an unmet need in the market by delivering the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures that, for the first time, delivers a minimally invasive approach to conventional venous closure,” said Andrew Glass, CEO, Vivasure Medical. “The results from our U.S. pivotal study, as well as the previous PerQseal studies, indicate that the PerQseal System is safe and effective for patients around the globe.”
