Data Published on Direct Flow Medical's TAVR System

February 25, 2014—Thirty-day results from the prospective, multicenter, nonrandomized evaluation of the Direct Flow Medical, Inc. (Santa Rosa, CA) transcatheter aortic valve for the treatment of severe aortic stenosis were published by Joachim Schofer, MD, et al in the Journal of the American College of Cardiology (JACC; 2014;63:763–768). 

The Direct Flow Medical system received CE Mark approval in January 2013 and is currently commercially available in Europe. The system consists of a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance before permanent implantation.

The 30-day data from the DISCOVER CE Mark trial were first presented in October 2012 at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. The 6-month data were presented at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California, in October by Dr. Schofer, who serves as Principal Investigator of the trial.

As summarized in JACC, the DISCOVER CE Mark trial evaluated 100 high-surgical-risk patients with severe aortic stenosis for the primary endpoint of freedom from all-cause mortality at 30 days. There were 75 patients in the group who were evaluable for the secondary endpoints. There were 25 patients in the prespecified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.

The investigators reported that for the primary endpoint, there was 99% freedom from all-cause mortality at 30 days. The 30-day combined freedom from patient safety event rate was 91%, as defined by VARC criteria. The overall device success rate was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% of patients (73 of 74), with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72), an effective orifice area of 1.5 ± 0.56 cm², and New York Heart Association functional class of I or II in 92% of cases.

The study demonstrates the safety and efficacy of the Direct Flow Medical system in high-surgical-risk patients with severe aortic stenosis and complex anatomy, and aortic regurgitation that was less than moderate in 99% of patients, concluded the investigators in JACC.