Vivasure Medical Announces Development Program for PerQseal Blue Sutureless Venous Closure Device

July 15, 2021—Vivasure Medical, an Ireland-based company focused on fully absorbable technology for percutaneous vessel closure, announced its development program for the company’s investigational PerQseal Blue. To advance its venous program to the clinical stage in 2022, the company advised it plans to initiate a study to evaluate and optimize PerQseal Blue.

According to the company, PerQseal Blue is designed for sutureless, fully absorbable, large-bore venous closure after percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement and transcatheter tricuspid valve repair or replacement.

The PerQseal Blue technology is based on the company’s PerQseal vascular closure device, which is approved in Europe for use in femoral arteries and is currently available to physicians in Europe for use in transcatheter endovascular procedures that require large-bore arterial vessel access, including transcatheter aortic valve repair or replacement, thoracic endovascular aneurysm repair, and endovascular abdominal aneurysm repair.

PerQseal Blue consists of an intravascular patch designed to seal the vessel from the inside, returning the vein to its natural state. The device has the potential to be the first sutureless, fully absorbable synthetic implant for large-bore venous closure after transcatheter mitral valve repair/replacement and transcatheter tricuspid valve repair/replacement procedures, stated Vivasure Medical.

The company noted that the PerQseal Blue development program was initiated in 2020 and is funded in part by a €2.5 million grant awarded by the European Innovation Council Accelerator (EIC). The EIC was part of the European Commission’s Horizon 2020 program and supports innovative entrepreneurs, small companies, and scientists planning to expand internationally.

“As transcatheter procedures for mitral and tricuspid valve treatment become increasingly common, there is a growing need for new venous closure options,” commented Azeem Latib, MD, in Vivasure Medical’s press release. “These minimally invasive procedures require much larger punctures, which often result in vascular complications.”

Dr. Latib, who is Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, New York, added, “Based on my experience using PerQseal for large-bore arteries in percutaneous endovascular procedures, I am optimistic for the potential of PerQseal Blue to provide a simple and safe option for venous closure that does not leave behind any sutures, metal implants, or collagen.”

Andrew Glass, Chief Executive Officer of Vivasure Medical, stated, “We’re thrilled to introduce PerQseal Blue to our product development portfolio as a potential new option specifically for large-bore venous closure following percutaneous cardiovascular procedures.”

In April, the company announced the start of Frontier V, a European multicenter study evaluating Vivasure Medical’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies and provide a more robust solution for the challenges and bleeding complications associated with large-bore arterial closure.