Direct Flow Medical has announced that it has received the CE mark for the first fully repositionable 29mm transcatheter aortic heart valve, delivered through its flexible, 18 French transfemoral delivery system. The transcatheter aortic valve implantation (TAVI) device is designed to virtually eliminate aortic regurgitation in all sizes of annulus by allowing complete assessment of haemodynamic performance and unlimited repositioning of the valve after full deployment in the native valve annulus.
A press release reports that the approval expands the population of patients who can be treated using the Direct Flow Medical valve to patients with annulus sizes ranging from 21mm to 28mm. It adds that the double-ring design of the Direct Flow Medical valve conforms to the anatomy and creates a tight and durable seal around the annulus. The system is designed to improve long-term survival of patients by resolving the clinical issues associated with current commercial valves. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement, minimising the risk of hemodynamic instability for patients. The Direct Flow Medical Transcatheter system is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacemen.
“As with the smaller sizes of the Direct Flow Medical valve, the implantation of the 29mm valve is precise and fully controllable,” said Christoph Naber, from the Contilia Heart and Vascular Center, Essen, Germany. “With this new valve size, a broader patient population will be able to benefit from the unique advantages of the Direct Flow Medical system.”