Onset's SoloPath Gains CE Mark Approval
July 28, 2009—Onset Medical Corporation (Irvine, CA) announced that it has received CE Mark approval to market the SoloPath endovascular access catheter in the European Union. The primary clinical applications for the SoloPath will be to provide quick and safe access of large therapeutic devices through the femoral and iliac arteries into the aortic artery.
According to the company, as many as 20% of patients who require replacement aortic heart valves have severe atherosclerotic disease in their leg arteries, which may prevent access of the new percutaneous aortic valves being marketed in Europe by Edwards Lifesciences (Irvine, CA) and Medtronic, Inc. (Minneapolis, MN). Onset's SoloPath is designed to provide access to these diseased arteries with a relatively small catheter size and then be expanded to accommodate the large diameter of percutaneous valve delivery devices. Therefore, the SoloPath may help broaden the number of patients who can be effectively treated with percutaneously implanted aortic heart valves. Another major clinical market for the SoloPath catheter is in the delivery of stent grafts for the treatment of aortic aneurysms. These aortic stent grafts require very large catheter delivery systems. The SoloPath will provide significant clinical advantages in the delivery of these stent grafts, Onset stated.
The SoloPath uses Onset's controlled deployment technology in a new approach to procedures requiring minimally invasive access to remote sites within the body. The SoloPath enters the body at approximately one-half the diameter of conventional access sheaths and navigates through the vascular anatomy. Once in position, the device is deployed by radial expansion to expand the sheath and remodel the tissue/vasculature in order to provide unrestricted access for the delivery of therapeutic devices. The company stated that early studies indicate that controlled deployment technology can allow the physician to achieve an easy, one-step access procedure that can potentially reduce vascular/tissue trauma and eliminate the need for other preoperative steps such as vascular stenting, which are often required for access with conventional devices. By eliminating a number of surgical maneuvers, use of the SoloPath may reduce procedural time, surgical expense, and patient recovery time, the company stated. Onset is conducting a multicenter study to further demonstrate the clinical superiority of the SoloPath versus current, conventional access devices. The company expects to launch the SoloPath during the fourth quarter of 2009.