Direct Flow Medical has announced that it has received the CE mark for its transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system.
According to a press release, the Direct Flow Medical Transcatheter Aortic Valve System is designed to virtually eliminate aortic regurgitation by allowing complete assessment of haemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus. It added that the unique, double-ring design of the valve creates a tight and durable seal around the annulus. The system is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.
Two sizes of valves—25mm and 27mm—will be commercially available in Europe immediately, both delivered via a flexible, 18 French system.
Post-procedural aortic regurgitation has been shown to be a predictor of long-term mortality. The 30-day, core-lab adjudicated results from the DISCOVER Trial, presented at the 2012 Transcatheter Cardiovascular Therapeutics (TCT) conference, showed that the Direct Flow Medical System achieved 97% freedom from all-cause mortality, with 97% of patients experiencing no or mild aortic regurgitation.
In addition, total average procedure time was 41.8 minutes with no post-dilatations required. The DISCOVER Trial is a prospective multicentre study conducted at seven leading European cardiology centers. Data from Direct Flow’s first-in-man study, presented at TCT 2012, showed a four-year survival rate of 54%, with 80% of patients exhibiting no aortic regurgitation, and 20% showing trace amounts.
“The Direct Flow Medical System is unique in many ways that combine to virtually eliminate aortic regurgitation, creating greater confidence in the outcome,” said Joachim Schofer, of the Medical Care Center, Hamburg, Germany, and co-principal investigator for the DISCOVER Trial.
“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. “This keeps the procedure calm throughout. 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 Direct Flow Medical System also reduces procedural risk by eliminating the need for rapid pacing during deployment and post-dilitation, which are common with other valves and can compromise hemodynamic stability during deployment and positioning.