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.