SANTA ROSA -- Direct Flow Medical, Inc. today said it has received approval to use its transcatheter aortic heart valve replacement in Europe.
Having obtained the CE Mark to sell the device on that continent, the Santa Rosa-based manufacturer said it will roll out a product and procedure that allows what was previously an open-heart surgery to be performed in a minimally invasive fashion, particularity for patients who need aortic valve replacement but may be too sick to undergo surgery.
The Direct Flow Medical Transcatheter Aortic Valve System is designed to improve the long-term survivability of patients by resolving the clinical issues associated with current commercial valves, according to the company.
Two sizes of valves -- 25 and 27 millimeter -- will be commercially available in Europe immediately. The replacement valves are designed to severely reduce the risk of post-procedural aortic regurgitation, which has been shown to be a predictor of long-term mortality, according to Direct Flow.
Results from the discover trial, presented at the 2012 Transcatheter Cardiovascular Therapeutics conference, showed the Direct Flow Medical System achieved 97 percent freedom from all-cause mortality, with 97 percent of patients experiencing no or mild aortic regurgitation, according to Direct Flow.
Additionally, total average procedure time was 41.8 minutes with no post-dilation required. The trial is a prospective multicenter study conducted at seven leading European cardiology centers. Data from Direct Flow’s first human study showed a four-year survival rate of 54 percent, with 80 percent of patients exhibiting no aortic regurgitation, and 20 percent showing trace amounts, according to Direct Flow.
“The Direct Flow Medical System is unique in many ways that combine to virtually eliminate aortic regurgitation, creating greater confidence in the outcome,” said Joachim Schofer, M.D., of the Medical Care Center in Hamburg, Germany, and co-principal investigator for the trial.
To support European commercialization, the company also announced the appointment of Dan Rose as vice president of sales and marketing. Most recently, Mr. Rose was vice president of commercial operations for Sequana Medical, a Swiss medical device company developing implantable pump systems. Prior to that, Mr. Rose held a number of sales and marketing leadership positions at Medtronic in Europe in both the interventional cardiology and cardiac surgery businesses.