The European Union has granted CE mark certification to Direct Flow Medical's transcatheter aortic heart valve system, featuring a double-ring design to create a tight and durable seal around the annulus.
Using pressurised saline and contrast solution, the Direct Flow Medical transcatheter aortic heart valve's polymer-based metal-free frame is expanded for placement, assessment and repositioning, according to the company.
The system also eliminates aortic regurgitation and reduces procedural risk by eliminating the need for rapid pacing during deployment and post-dilitation.
During the company's prospective multi-centre, 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 Centre spokesperson and trial co-principal investigator professor Dr 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 said.
"Delivery is also easy, as the flexible, low-profile design has enabled me to navigate vessels as small as 5.2mm without vascular complications."
The company's Direct Flow 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.
Direct Flow Medical said two new sizes of valve, 25mm and 27mm, which are delivered via a flexible 18 French delivery system, will be available in Europe.