News | October 10, 2014

Direct Flow Medical Receives CE Mark

Direct Flow's transfemoral aortic heart valve delivery system is ready for commercial purchasing

October 10, 2014 ­­­­– Direct Flow Medical Inc. 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 controlled delivery of the Direct Flow Medical valve. The system features a low profile, ultra-flexible sheath that allows for easy access to 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 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 5.2 mm 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 United States, the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial.

The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the United States, Canada or Japan.

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