Ireland-based Vivasure Medical has received CE mark approval for its fully bioabsorbable percutaneous vascular closure device to be used in large-bore femoral arteriotomies.
Designed based on the firm’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 result from percutaneous transcatheter procedures.
An arteriotomy is a puncture hole in a vessel in the groin, which provides access to arteries for catheter-based procedures.
Vivasure Medical co-founder and CEO Gerard Brett said: "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.
"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."
The Vivasure closure system is comprised of a delivery system and single-use patch-like device.
According to the firm, the device was assessed 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.