Direct Flow Medical Receives CE Mark for 23-mm Transcatheter Aortic Valve

August 21, 2014—Direct Flow Medical, Inc. announced that it has received CE Mark approval for its 23-mm valve, which is part of the company’s transcatheter aortic valve system and expands the patient population that can be treated with its technology. The company also announced CE Mark approval for implantation of all of its valves without the use of contrast media, protecting patients from kidney injury during transcatheter aortic valve replacement.
 
According to the  press release, Direct Flow Medical’s valve portfolio now includes 23-, 25-, 27-, and 29-mm sizes, which can treat patients with annulus sizes from 19 to 28 mm. The valves feature a double-ring design that conforms to the anatomy and creates a tight and durable seal around the annulus. They also allow for assessment of hemodynamic performance and repositioning until optimal results are achieved. All of the valves can be delivered through the same low-profile, flexible delivery system. 
 
The Direct Flow Medical valve is designed to improve transcatheter aortic valve replacement outcomes by reducing aortic regurgitation, offering unlimited repositioning during the procedure, and reducing overall complications. 

The Direct Flow Medical transcatheter aortic valve system is commercially available in Europe. In the United states, the company is progressing toward regulatory approval and is currently enrolling patients in its SALUS pivotal trial, the company noted.