Vivasure Medical PerQseal+ Evaluated in United States Early Feasibility Study for Large-Bore Closure

March 15, 2022—Vivasure Medical, an Ireland-based developer of fully absorbable percutaneous vessel closure technology, announced that the first patient was treated in a United States early feasibility study evaluating the PerQseal+.

The study is designed to evaluate the company’s next-generation PerQseal+ in percutaneous transcatheter aortic valve replacement procedures. PerQseal+ is intended for managing challenges and bleeding complications associated with large-bore arterial vessel closure.

Robert Pyo, MD, treated the first patient in the study at Stony Brook University Hospital in Stony Brook, New York. Dr. Pyo is Director of Interventional Cardiology and Codirector of Structural Heart Cardiology, Stony Brook Medicine.

The study’s Principal Investigator is William Gray, MD. Dr. Gray is System Chief, Division of Cardiovascular Disease at Main Line Health and Codirector at the Lankenau Heart Institute in Philadelphia, Pennsylvania.

“We are pleased to participate in this study of the PerQseal+ vessel closure device, a promising tool intended to advance the standard of care for patients undergoing minimally invasive structural heart procedures,” commented Dr. Gray in the company’s press release. “This study will allow us to evaluate PerQseal+ for safe, efficient, and secure large-bore vessel closure with a novel nonsuture mechanism design, which has great potential for effectively managing vascular access without the complications typically associated with large-bore closure.”

According to Vivasure Medical, the first-generation PerQseal device is a sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe. The PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state and does not leave the remains of any collagen, metal implants, or sutures.

The next-generation PerQseal+ device has an enhanced bioabsorbable patch designed to address more complex patient anatomies and is currently under clinical evaluation in Europe.