CE Mark Approved for Vivasure Medical's Fully Bioabsorbable Percutaneous Closure Device for Large-Bore Transcatheter Procedures

January 8, 2016—Vivasure Medical announced European CE Mark approval of its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The Vivasure closure device is the first product from the company’s PerQseal technology platform, which provides a bioabsorbable, sutureless, and fully synthetic option to close large arteriotomies that result from percutaneous transcatheter procedures.

The Vivasure closure device includes a delivery system and single-use patch-like device. The system has been evaluated in clinical studies, with patients treated in four European countries, achieving 97% device technical success with no major device-related complications. Long-term follow-up data have been collected to 12-months postprocedure. The Vivasure closure device is not currently approved in the United States.

The company noted that large-bore arteriotomies, such as those made to facilitate transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair, have traditionally required a surgical cut-down and sutured repair via a 3- to 5-cm incision. 

In Vivasure’s press release, Michael Laule, MD, commented, “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. Laule is a cardiologist at Charité University Hospital in Berlin, Germany.

Paul Teirstein, MD, who is Chief of Cardiology and Director of Interventional Cardiology for Scripps Clinic and Director of the Scripps Prebys Cardiovascular Institute for Scripps Health in San Diego, California, serves as Chief Medical Officer of Vivasure Medical. Dr. Teirstein stated, “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.”