Direct Flow Medical Inc. announced the receipt of a CE mark for its transcatheter aortic heart valve system Jan. 28.

The CE mark is based on results from 33 patients in the DISCOVER trial, in which 97 percent of subjects experienced no or mild aortic regurgitation. The DISCOVER trial also showed a 97 percent rate of freedom from all-cause mortality after 30 days; the firm’s first-in-man data showed a four-year survival rate of 54 percent. Joachim Schofer of the Hamburg University Cardiovascular Center presented the DISCOVER results at the 2012 TCT Conference in Miami Beach, Fla. (See Also see "TCT Conference In Brief" - Medtech Insight, 29 October, 2012..)

The company is supporting its European launch by hiring a pair of new executives.

The small Santa Rosa, Calif.-based company says its TAVR device is designed to significantly reduce aortic regurgitation, a predictor of long-term mortality according to studies cited by the company. The valve has a metal-free frame and a low-profile transfemoral delivery system, allowing for assessment of performance after deployment to eliminate regurgitation.

“Its novel design enables us to fully assess outcomes and adjust or retrieve the valve at any time during the procedure, without creating hemodynamic stress for the patient. This keeps the procedure calm throughout. Delivery is also easy, as the flexible, low-profile design has enabled me to navigate vessels as small as 5.2 mm without vascular complications,” Schofer said.

Instead of metal, the Direct Flow’s device is made of a polymer that can be expanded with a pressurized saline and contrast system to secure the valve in place. The firm also touts the double-ring design of the valve, arguing that it creates a tight seal around the annulus.

The device is entering an increasingly crowded transcatheter aortic valve marketplace. Edwards Lifesciences Corp.’s Sapien device and Medtronic PLC’s CoreValve control most of the European market. But upstarts Symetis SA (Acurate TA)and German firm JenaValve Technology GMBH (JenaValve) gained CE marks for their transapical-delivered valve systems in Europe in 2011. (See [A#01111010010].) And St. Jude Medical Inc. (Portico) and Boston Scientific Corp. (Lotus) plan to launch TAVR devices in Europe in 2013.

Most of these companies, including Direct Flow, are years away from entering the U.S. market, where Edwards currently has the TAVR market to itself. (See Also see "Edwards’ Sapien Ramp-Up Successful, But Medicare Policy Makes For Some Hurdles" - Medtech Insight, 30 July, 2012..)

Direct Flow Medical Secures CE Mark For TAVR Device

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