Vivasure Medical has announced initial positive results from its US IDE PATCH pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system. Results were presented at TCT 2024 (27–30 October, Washington, DC, USA)
PerQseal is the a sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.
It is used for large hole arterial access and is needed for a variety of procedures including transcatheter aortic valve implantation (TAVI) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.
Vivasure’s US IDE PATCH clinical study, a multicentre, single-arm, pivotal study, enrolled over 145 patients across 17 US and European investigational sites and evaluated the safety and efficacy of PerQseal when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22F sheaths (arteriotomies up to 26Fr) in subjects undergoing percutaneous catheter-based interventional procedures.
Data presented at TCT show a 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 haemostasis following percutaneous procedures were a median time of zero minutes.
“Complications from large hole vascular closure remain vexing, impacting patients and requiring additional time and resources. As interventionalists, we need new technologies to improve both outcomes and procedural efficiency,” said William Gray (Main Line Health, Philadelphia, USA), principal investigator of the PATCH study. “The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”
