Irish firm Vivasure Medical has received CE Mark approval for its fully bioabsorbable percutaneous vascular closure device developed for use in large-bore femoral arteriotomies.
Based on the company’s patented PerQseal technology platform, the Vivasure closure device is claimed to be the only approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which are a result of percutaneous transcatheter procedures.
An arteriotomy is a puncture hole in a vessel in the groin, which provides access to arteries for catheter-based procedures.
Charité University Hospital Berlin cardiologist Michael Laule said: “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 utilise a fully percutaneous procedure to repair the access site.”
The company said large-bore arteriotomies, such as those made to facilitate transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR), traditionally required a surgical cut-down and sutured repair via a 3cm to 5cm incision.
Vivasure Medical chief medical officer Dr Paul Teirstein said: “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.”
The Vivasure closure device provides physicians an easy-to-use and fully percutaneous alternative to sutured repair, and is comprised of a delivery system and single-use patch-like device.
According to the company, the device was evaluated in clinical studies with patients treated in four EU countries, achieving 97% device technical success with no major device related complications.
The Vivasure closure device has not yet received approval in the US.