Direct Flow Medical, a medical device company developing and commercializing transcatheter heart valve therapy products to treat structural heart disease, today announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.
The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.
The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. "I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception.
The new DirecTrack system is a major step forward in positioning control and smooth valve delivery," stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, "I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome."
"We’re pleased to provide physicians with this latest advance in TAVI procedural control," stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, "The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome."
Direct Flow Medical, Inc. is a privately-held medical device company developing and commercializing novel transcatheter heart valve therapy products to treat structural heart disease.
The company is sponsoring the SALUS Pivotal Trial in the U.S. to investigate the Direct Flow Medical Transcatheter Aortic Valve System for treatment of high and extreme risk severe symptomatic aortic stenosis.
The system is commercially available in Europe for treatment of patients with aortic stenosis who are at extreme surgical risk.