Direct Flow Medical's 29-mm TAVR System Approved in Europe

January 9, 2014—Direct Flow Medical, Inc. (Santa Rosa, CA) announced it has received European CE Mark approval for the company's fully repositionable 29-mm transcatheter aortic heart valve with a flexible, 18-F transfemoral delivery system. The approval expands the population of patients who can be treated using the Direct Flow Medical valve to patients with annulus sizes ranging from 21 mm to 28 mm.

The company advised that 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. The company's 25-mm, 27-mm, and 29-mm transcatheter aortic valves delivered through its 18-F delivery system have received CE Mark approval and are commercially available in Europe.

“As with the smaller sizes of the Direct Flow Medical valve, the implantation of the 29-mm valve is precise and fully controllable,” commented Christoph Naber, MD, in the company's press release. “With this new valve size, a broader patient population will be able to benefit from the unique advantages of the Direct Flow Medical system.” Dr. Naber is from the Contilia Heart and Vascular Center in Essen, Germany.

According to the company, 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 device's double-ring design conforms to the anatomy and creates a tight and durable seal around the annulus. The system avoids rapid pacing of the heart during deployment and does not require postdilatation following placement, minimizing the risk of hemodynamic instability for patients, stated Direct Flow Medical.

The company advised that 6-month data from the DISCOVER CE Mark trial confirm the system's ability to virtually eliminate significant aortic regurgitation. The data were presented in October at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. Through 6 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 major or minor strokes or myocardial infarction in the evaluable cohort between 30 days and 6 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, noted the company.