Direct Flow Medical has received CE Mark for its transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system. The design also creates a seal around the annulus.
Two sizes of valves—25mm and 27mm—will be commercially available in Europe immediately, both delivered via an 18 French system.
To support European commercialization, the Santa Rosa, Calif.-based company also appointed Dan Rose as vice president of sales and marketing. Most recently, Rose was vice president of commercial operations for Sequana Medical, an Swiss medical device company developing implantable pump systems. Prior to that, Rose held a number of sales and marketing leadership positions at Medtronic in Europe in both the interventional cardiology and cardiac surgery businesses.