Direct Flow Medical, a medical device company for the treatment of heart valve disease, has completed a $27 million second round of financing its Series B financing co-led by Johnson & Johnson Development Corporation and Foundation Medical Partners. With the funding, the firm will initiate clinical trials in Europe of its catheter system.
The Santa Rosa, Calif.-based Direct Flow said it has developed a catheter-based system to replace the aortic valve percutaneously in patients with valvular disease. The device is an implantable pericardial tissue valve that allows delivery via a transfemoral approach. The design also is intended to allow the physician to obtain full hemodynamic data and imaging prior to final device placement, according to the company.
Direct Flow also announced that it has commenced its European clinical trial with the first device implanted 3 weeks ago in an 81-year old, non-operative patient at the University Heart Center Hamburg under the direction of Joachim Schofer, MD, a interventional cardiologist and Hermann Reichenspurner, MD, chief of cardiac surgery. Schofer delivered the device in the cardiac catheter lab via the femoral artery. Reginald Low, MD, an interventional cardiologist at University of California, Davis and Steven Bolling, MD, a cardiac surgeon at the University of Michigan, are monitoring the initial clinical case.