CE Mark for transfemoral aortic heart valve

Santa Rosa, California – Direct Flow Medical Inc. officials announced the company has received the CE Mark for an enhanced transfemoral delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

The enhanced Direct Flow Medical delivery system offers an ergonomic handle designed for easy, precise, and controlled delivery of the Direct Flow Medical valve. 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. All of the Direct Flow Medical valves can be delivered through the same, low profile and flexible delivery system.

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 hemodynamic performance and unlimited repositioning until optimal results are obtained. The company now 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 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, M.D. “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.”

The Direct Flow Medical valve is designed to improve TAVI outcomes by virtually eliminating aortic regurgitation, offering unlimited repositionability during the procedure and reducing overall complications.

“We have been able to access vessels as small as 5.2mm with the Direct Flow Medical delivery system. The system is very flexible and tracks very well in highly calcified anatomies,” said Christoph Naber, M.D. from the Contilia Heart and Vascular Center in Essen, Germany. “The newly approved system offers enhanced precision and improved control for valve delivery while being extremely simple to use.”

The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe. In the U.S., the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial.

The benefits of the Direct Flow Medical Transcatheter Aortic Valve System are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the Direct Flow Medical System incorporates a polymer frame, which is expanded using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The unique double-ring design of the valve creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement. 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 (SAVR).The metal-free design enables a low-profile, fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.

Source: Direct Flow Medical Inc.