Direct Flow Medical received CE Mark approval for its 23mm transcatheter aortic valve system, allowing the product to be used on patients with annuli down to 19mm. Moreover, the company won the CE Mark for contrast-free implantation of its line of transcatheter valves, helping avoid unnecessary damage to the kidneys that contrast mediums often bring.
The Direct Flow valves are all placed using the same delivery system and can be repositioned until a perfect fit is achieved. The valve is positioned over the diseased natural valve and does not require any modification to the patient’s anatomy.
From the announcement:
The company now has a valve portfolio that includes 23mm, 25mm, 27mm and 29mm valves, which can treat patients with annulus sizes from 19mm to 28mm. All Direct Flow Medical valves feature a unique, double-ring design that conforms to the anatomy and creates a tight and durable seal around the annulus. The valves allow for complete assessment of hemodynamic performance and unlimited repositioning until optimal results are obtained. All valves can be delivered through the same, low profile, and flexible delivery system.
Press release: DIRECT FLOW MEDICAL®, INC. RECEIVES CE MARK FOR 23mm VALVE AND FOR IMPLANTATION OF ALL SIZES OF ITS TRANSCATHETER AORTIC HEART VALVE WITHOUT USE OF CONTRAST…