An endovascular surgical device could benefit patients with severe deep venous insufficiency, according to a recent study published in Vascular and Endovascular Surgery.
EnVVeno Medical Corporation's VenoValve, a one-way circulatory valve, was associated with a 54 percent improvement in backward blood flow prevention and a 76 percent improvement in pain, the company said March 9. It is designed to help restore proper directional blood flow up the leg to return sufficient blood back to the heart.
"The current standard of care for deep venous [chronic venous insufficiency]has significant shortcomings, and we believe the VenoValve could be the effective solution that frustrated doctors and their patients have been seeking for decades," EnVVeno CEO Robert Berman said.
The FDA has granted VenoValve with its breakthrough device designation, EnVVeno said.
The trial was a non-randomized study with 11 patients in a single center.