Vivasure Medical has announced it has enrolled the first patients in the company’s PerQseal PATCH clinical study, a multicentre, 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 by Vijay Iyer, chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital (all Buffalo, USA).
“With the recent proliferation of large bore arterial access, there is 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 William Gray, system chief in the Division of Cardiovascular Disease at Main Line Health and co-director at the Lankenau Heart Institute (both Philadelphia, USA) 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 is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques, the company claims.
“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 Iyer. “I am honoured to participate in this study and look forward to gathering additional clinical evidence supporting this innovation’s potential benefits.”
Vivasure’s pivotal study will enrol up to 171 patients across the USA and up to 90 patients in up to eight European investigational sites. The data will support a premarket approval submission to the US Food and Drug Administration (FDA).