Direct Flow Medical, a transcatheter heart valve innovator, has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve, delivered through its flexible, 18 French transfemoral delivery system.
The Direct Flow Medical valve is designed to virtually eliminate aortic regurgitation in all sizes of annulus by allowing complete assessment of hemodynamic performance and unlimited repositioning of the valve after full deployment in the native valve annulus.
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.
Direct Flow Medical president and CEO Bernard Lyons noted until now, patients with large annulus sizes who could not undergo surgical valve replacement had limited options, as other commercially available valves often leave significant aortic regurgitation at larger sizes and are not repositionable or retrievable.
"With the addition of the 29mm valve to our portfolio, we can now greatly improve outcomes for this group of patients, as well," Lyons added.
The unique, 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, minimizing the risk of hemodynamic instability for patients. The Direct Flow Medical transcatheter aortic valve system is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR).
Six month data from the Discover CE Mark Trial, recently presented at the 2013 Transcatheter Cardiovascular Therapeutics (TCT) conference, confirm the system’s ability to virtually eliminate significant aortic regurgitation.
Through six months, no patient experienced moderate or severe aortic regurgitation and there was a 96% overall survival rate, with 90% of patients in functional Class I or II. The system also demonstrated a strong safety profile, with a 97% VARC defined combined safety rate and no incidence of strokes (major or minor) or myocardial infarction in the evaluable cohort between 30 days and six months.
The Discover Trial is a prospective, multicenter study of the Direct Flow Medical system conducted at nine European sites in 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair.
The Direct Flow Medical portfolio now includes 25mm, 27mm and 29mm transcatheter aortic valves, all delivered through its flexible, 18 French delivery system, which have received the CE Mark and are currently commercially available in Europe.