Study will evaluate the safety and efficacy of Vivasure's PerQseal Closure Device System designed for large arteriotomies
Vivasure Medical, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company's PerQseal PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal Closure Device System. The first patients were enrolled at Kaleida Health's Buffalo General Medical Center-Gates Vascular Institute in Buffalo, New York by Dr. Vijay Iyer, Chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital.
"With the recent proliferation of large bore arterial access, there's a moment at the completion of each procedure when vessel management is critical and clinicians must quickly and effectively close it to reduce unnecessary, potentially life-threatening bleeding," said Dr. William Gray, system chief in the division of cardiovascular disease at Main Line Health, co-director at the Lankenau Heart Institute in Philadelphia and the principal investigator for the PerQseal PATCH study. "I look forward to evaluating the PerQseal technology and its simplified, controlled technique with the ultimate goal of reducing vascular complications for these patients."
Large hole arterial access is required for clinicians to perform percutaneous cardiovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.
PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. It's placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.
"Large bore closure can be challenging, and PerQseal is a promising technology for interventional cardiologists as a growing number of treatment options for patients utilise fully percutaneous approaches," said Dr. Iyer. "I'm honored to participate in this study and look forward to gathering additional clinical evidence supporting this innovation's potential benefits."
Vivasure's pivotal study will enroll up to 171 patients across the U.S. and up to 90 patients in up to eight European investigational sites. The data will support a pre-market approval submission to the U.S. Food and Drug Administration (FDA).
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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Health+Commerce
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