Data from U.S. IDE PATCH Pivotal Study presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference will support a pre-market approval submission to the FDA
Results demonstrate Vivasure’s PerQseal® Closure Device achieved closure with very low rates of major vascular complications and rapid times to hemostasis
GALWAY, Ireland--(BUSINESS WIRE)--Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced initial positive results from its U.S. IDE PATCH Pivotal Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C.
The Vivasure PerQseal® Closure Device System (PerQSeal) is the first 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 replacement (TAVR) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.
Vivasure’s U.S. IDE PATCH Clinical Study, a multi-center, single-arm, pivotal study, enrolled over 145 patients across 17 U.S. and European investigational sites and evaluated the safety and efficacy of 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 presented at TCT show an impressively 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.
“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 A. Gray, MD, principal investigator of the PATCH study and system chief in the division of cardiovascular disease at Main Line Health, Philadelphia. “The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”
“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,” explained 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.”
About Vivasure Medical
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.
The PerQseal® is not available for sale in the United States.
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Jenna Kane
Health+Commerce
jennakane@healthandcommerce.com
480.388.9587
