Irish absorbable tech company, Vivasure Medical, has announced results from a US Investigational Device Exemption (IDE) PATCH pivotal trial finding that its fully absorbable synthetic implement for use in procedures such as transcatheter aortic valve replacements (TAVR) cuts post-procedure complications.
Designed for use in procedures requiring large-bore vessel punctures, the Vivasure PerQseal trial saw almost immediate haemostasis in the majority of patients with no signs of bleeding within a minute. At the same time, using the Valve Academic Research Consortium 3 (VARC-3) major complication rate as a measurement, 0.8% of patients saw complications at discharge.
Related: CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants
Presenting its findings before the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington D.C. the device is intended as a replacement for suture- or collagen-based closure devices typically used in procedures where implements and tools need to be naturally absorbable into the body.
William Gray, principal investigator of the PATCH study, said: “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.
“The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”
The multi-center, single-arm, pivotal study, enrolled over 145 patients across 17 US and European sites and sought to evaluate the safety and efficacy of PerQseal when used to achieve haemostasis of common femoral arteriotomies in patients undergoing percutaneous catheter-based interventional procedures.
Andrew Glass, CEO of Vivasure Medical, said: “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, deliver a minimally invasive approach to conventional venous closure.
“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.”
