Direct Flow Medical has announced it has received the CE Mark for an enhanced transfemoral delivery system for its transcatheter aortic valve implantation (TAVI) valve. It says that the system 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.
A company press release reports that the Direct Flow Medical valve features 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 haemodynamic performance and unlimited repositioning until optimal results are obtained. 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.
“Direct Flow Medical continues to innovate with the focus on improving patient outcomes. The approval of the enhanced Direct Flow Medical delivery system is further evidence of our commitment to the medical community that treats TAVI patients,” said Direct Flow Medical chief medical officer Charles Davidson, “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.”