Ireland-based Vivasure Medical said today it won CE Mark approval in the European Union for its bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies.
The closure device is the 1st from the company’s PerQseal platform, and Vivasure claims its the only approved bioabsorbable, sutureless synthetic option to close large arteriotomies that result from percutaneous transcatheter procedures.
“Percutaneous transfemoral access is a key enabler for TAVR procedures, which are rapidly becoming standard of care for patients with aortic valve disease. The Vivasure closure device is an easy-to-use option that promises to significantly improve the patient experience and shorten overall procedure times by allowing physicians to utilize a fully percutaneous procedure to repair the access site,” Dr. Michael Laule of Berlin’s Charité University Hospital said in a press release.
The newly-approved closure device includes a delivery system and single-use patch-like device, the company said. Approval came based at least partially on clinical studies which reported 97% device technical success with no major device-related complications.
“The bioabsorbable nature of the Vivasure closure device allows the surgeon to provide a complete repair at the surgery site, which helps avoid stenosis and maintains the integrity of the vessel. The demand for bioabsorbable solutions is growing as the transient nature of these products continues to demonstrate as good or better therapeutic results for patients,” chief medical officer Dr. Paul Teirstein said in prepared remarks.
The device is designed to close arteriotomies, or punctured holes in vessels in the groin used during catheter based procedures. Vivasure’s device provides an alternative to traditional repair via suture.
“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive procedures that offer improved clinical outcomes and faster recovery times over the open surgery alternative. The Vivasure closure device is intended to further facilitate the less invasive nature of these treatments. CE Mark is an important milestone for Vivasure as we continue development of our technology, which we plan to launch in Europe in the coming months,” CEO Gerard Brett said in a prepared statement.