Direct Flow Medical has obtained CE mark approval for its transcatheter aortic heart valve system, which features double-ring design for creating a tight and durable seal around the annulus.
The Direct Flow Medical transcatheter aortic heart valve, which is now available in two new sizes of valves including 25mm and 27mm, is delivered via a flexible 18 French delivery system.
The company said the heart valve system uses pressurized saline and contrast solution to expand its polymer-based metal-free frame for placement, assessment and repositioning.
During the company’s prospective multi-center, 30-day Discover trial, the system achieved 97% freedom from all-cause mortality, with 97% of patients experiencing no or mild aortic regurgitation.
The trial also demonstrated a total average procedure time of 41.8 minutes with no post-dilatations required.
Medical Care Center spokesperson and trial co-principal investigator professor Joachim Schofer said the heart valve system eliminates aortic regurgitation and creates greater confidence in the outcome.
"Its novel design enables us to fully assess outcomes and adjust or retrieve the valve at any time during the procedure, without creating hemodynamic stress for the patient," Schofer added.
"Delivery is also easy, as the flexible, low-profile design has enabled me to navigate vessels as small as 5.2 mm without vascular complications."
The company’s first-in-man study has also demonstrated a four-year survival rate of 54%, with 80% of patients exhibiting no aortic regurgitation, and 20 % showing trace amounts.