Vivasure Medical Begins Frontier V Study of Next-Generation PerQseal+ Large-Bore Closure Device

April 20, 2021—Vivasure Medical announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal+, the next generation of the company’s PerQseal device, a sutureless, fully absorbable synthetic implant for closure of large-bore vessel punctures.

The first patient was enrolled by study investigator Fernando Gatto, MD, Head of Cardiac Catheter Labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany. Christian Frerker, MD, Head of Structural Heart Disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, is Principal Investigator of the Frontier V study.

According to the company, the PerQseal device is currently available to physicians in Europe for use in transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair, and endovascular abdominal aneurysm repair. PerQseal is not available for sale in the United States.

The next-generation PerQseal+ features an enhanced bioabsorbable patch designed to address more complex patient anatomies and manage the challenges and bleeding complications associated with large-bore closure.

“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” commented Dr. Gatto in the company’s announcement. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”

Dr. Frerker added, “The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large-bore closure. This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”