Direct Flow Medical releases clinical results of its new Percutaneous Aortic Valve System

Oct 6 2009

Direct Flow Medical, Inc., www.directflowmedical.com, released its 12 month data from the initial clinical trial for a new device to treat valve disease without invasive thoracic surgery. Direct Flow Medical is a privately held, emerging medical device company developing a next-generation, catheter based, percutaneous delivered prosthetic aortic valve. At the Transcatheter Cardiovascular Therapeutics (TCT) meeting last month Professor Joachim Schofer from Hamburg, Germany presented the prospective, non randomized data from the European Feasibility and Safety Trial. A total of 31 patients were enrolled at 2 centers in this first in human clinical trial.

The 1 year risk adjusted survival rate in this study was 72% which is significantly better than the predicted survival of this patient population if they were treated by conventional surgery or medical management. The survival rate is comparable to survival rates reported with the first generation transcatheter aortic valve interventional (TAVI) devices now commercially available in Europe.

The patients in the study also benefited from a significant improvement in quality of life as measured by NYHA functional class. Most patients had an improvement of at least two functional classes. “The improvement in functional class appears to be due to the low incidence of perivalvular leak, and the unique ability of the Direct Flow device to seal to the native annulus,” stated Dr. Hendrik Treede, a cardiothoracic surgeon and study co-investigator in Hamburg.

Also at the TCT meeting, Professor Schofer reported 2 year data on the first patient treated with the Direct Flow Medical 22F Percutaneous Aortic Valve (PAV) System. Before treatment the 81 year old patient was suffering from critical aortic stenosis with an effective orifice area of 0.56cm² and was NYHA Class III. Because of severe co-morbidities, the patient was not a surgical candidate. At the two year follow-up the excellent acute clinical result was maintained; the patient remains NYHA Class I with a mean pressure gradient of 10mmHg, an effective orifice area of 1.98cm² and he maintains an active life style. An additional 6 patients implanted with the Direct Flow Medical device are surviving beyond 18 months post treatment despite having an average age of 82 years and a logistic EuroScore of greater than 27 at implant.

Professor Schofer stated, “We are pleased to report the positive data, results and clinical outcomes demonstrated in our patients at 1 year post implant and beyond, particularly in the areas of stable post procedure gradients and improved NYHA functional class. We anticipate that with the development of the new 18F device from Direct Flow Medical we will be able to accelerate patient enrollment and increase our clinical experience with this unique, next generation device.”

SOURCE: Direct Flow Medical, Inc.