CE Mark for Direct Flow Medical’s Enhanced Transfemoral TAVI Delivery System

Transcatheter heart valve innovator Direct Flow Medical®, Inc., has announced it has received the CE Mark for an enhanced transfemoral delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

Background

We get a little misty eyed when talking about Direct Flow Medical as a quick search of our site might testify. After all, here is a medical device innovator that isn’t afraid to break the mold and is offering the most innovative transcatheter replacement heart valve out there at the present time. It seems they’re determined to address customer demand and focus on making the system as ergonomic as it can be with new enhancements that include a revised 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.

Physician comments

“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.”

Company comments

“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 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.

Source: Direct Flow Medical, Inc., Business Wire

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