Direct Flow Medical, a transcatheter heart valve innovator focused on improving patient outcomes, has received the CE Mark for an improved transfemoral delivery system, the Transcatheter Aortic Valve System.
The improved delivery system provides an ergonomic handle designed for easy, precise and controlled delivery of the Direct Flow Medical valve.
It features a low profile, ultra-flexible sheath that, in addition to the non-metallic valve, allows for easy access and excellent trackability through calcified and tortuous anatomies.
The company said that all of the Direct Flow Medical valves can be delivered through the same, low profile and flexible delivery system.
The double-ring design of the valve conforms to the anatomy and creates a tight and durable seal around the annulus.
The valves allow for complete evaluation of hemodynamic performance and unlimited repositioning until optimal results are obtained.
Currently, the company has a valve portfolio that includes 23mm, 25mm, 27mm and 27mm valves, which can treat patients with annulus sizes from 19mm to 28mm.
Direct Flow Medical chief medical officer Dr Charles Davidson said the approval of the enhanced Direct Flow Medical delivery system is further evidence of the company’s commitment to the medical community that treats TAVI patients.
"We continue to deliver on our promise to develop innovative products delivering the best patient outcomes, and continue to investigate new indications for our unique therapeutic platform," Davidson said.
The valve system is designed to improve TAVI outcomes by virtually eliminating aortic regurgitation, providing unlimited repositionability during the procedure and reducing overall complications.