Vivasure Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. According to Vivasure, this is the world’s first approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.
The proprietary Vivasure closure device—which is the first product from the company’s patented PerQseal technology—is designed to offer physicians an easy-to-use and fully percutaneous (through the skin) alternative to the 3-5cm sutured repair traditionally associated with transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR).
“Percutaneous transfemoral access is a key enabler for TAVR procedures, which are rapidly becoming standard of care for patients with aortic valve disease,” says Michael Laule, cardiologist at Charité University Hospital, Berlin. “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 utilise a fully percutaneous procedure to repair the access site.”
“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,” says Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic, director of the Scripps Prebys Cardiovascular Institute for Scripps Health, and chief medical officer of Vivasure Medical. “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.”