Direct Flow Medical Tavi shows excellent outcomes at six months

29 October 2013

Results from European trial presented at TCT Conference in San Francisco

Direct Flow Medical Tavi shows excellent outcomes at six months

Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced six-month data from the fully-enrolled DISCOVER CE Mark Trial that continue to affirm the excellent outcomes and strong safety profile of the Direct Flow Medical® Transcatheter Aortic Valve System. The data, which were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, demonstrated sustained results at six months, with 96 percent freedom from all-cause mortality and no incidence of moderate or severe post-procedural aortic regurgitation. Principal Investigator Joachim Schofer, M.D., from the Medical Care Center, Hamburg, Germany, presented the results.

The results from the DISCOVER Trial confirm the system’s ability to virtually eliminate aortic regurgitation, with no patient experiencing moderate or severe aortic regurgitation at six months. Additionally, the mean gradient of 13.0mmHg as measured by echocardiography at six months demonstrates that the Direct Flow Medical valve can significantly reduce, and maintain, low transvalvular gradients over time. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory.

The strong safety profile of the Direct Flow Medical system was confirmed with a 97 percent VARC defined Combined Safety rate at six months with no additional strokes (major or minor) and no patient experiencing a myocardial infarction in the evaluable cohort. The system avoids rapid pacing of the heart during deployment and does not require post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. At six months, 78.6 percent of patients improved by one or more New York Heart Association (NYHA) functional classes and 90 percent of patients were classified as NYHA Class I or II.

“These data show that the excellent results obtained with the Direct Flow Medical system are sustainable over time,” said Professor Schofer. “The Direct Flow Medical system is able to virtually eliminate aortic regurgitation with outstanding patient safety. These results continue to be unprecedented for a TAVI device.”

The Direct Flow Medical system received the CE Mark in January 2013 and is currently commercially available in Europe.

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