October 6, 2009 – Direct Flow Medical Inc. released its One-year data from the initial clinical trial for its transcatheter prosthetic aortic valve during the recent Transcatheter Cardiovascular Therapeutics (TCT) 2009 meeting .
Professor Joachim Schofer from Hamburg, Germany presented the prospective, nonrandomized data from the European Feasibility and Safety Trial. A total of 31 patients were enrolled at two centers in this first in human clinical trial. The one-year risk adjusted survival rate in this study was 72 percent, 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,” said Dr. Hendrik Treede, a cardiothoracic surgeon and study coinvestigator in Hamburg.
Also at the TCT meeting, professor Schofer reported two-year data on the first patient treated with the Direct Flow Medical 22 Fr. Percutaneous Aortic Valve (PAV) System. Before treatment, the 81-year-old patient was suffering from critical aortic stenosis with an effective orifice area of 0.56 cm2 and was NYHA Class III. Because of severe comorbidities, 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 10 mmHg, an effective orifice area of 1.98 cm2 and he maintains an active life style. An additional six patients implanted with the Direct Flow Medical device are surviving beyond 18 months post treatment despite having an average age of 82 and a logistic EuroScore of greater than 27 at implant.
“We are pleased to report the positive data, results and clinical outcomes demonstrated in our patients at one-year post implant and beyond, particularly in the areas of stable post procedure gradients and improved NYHA functional class,” said professor Schofer. “We anticipate that with the development of the new 18 Fr. device from Direct Flow Medical we will be able to accelerate patient enrollment and increase our clinical experience with this unique, next generation device.”
For more information: www.directflowmedical.com