Onset's SoloPath Access Catheter Cleared for Additional Size Applications

August 10, 2010—Onset Medical Corporation (Irvine, CA) announced that the company has received US Food and Drug Administration 510(k) marketing clearance for new access applications of the SoloPath transfemoral endovascular access catheter. The device is an enabling platform that can establish a repeatable and predictable method of access, thus providing the potential for a larger patient population to be successfully treated. Onset stated that the SoloPath may help broaden the number of patients who can be effectively treated percutaneously with femoral/iliac artery stent grafts, aortic stent grafts (including those for treating abdominal aortic aneurysms that require large catheter delivery systems), and new technology such as percutaneous aortic heart valves.

According to the company, the SoloPath endovascular access catheter uses Onset's controlled deployment technology that allows the device to enter the body at approximately one-half the diameter of conventional access sheaths. Once in position, the device is deployed using radial expansion to expand the sheath and remodel the tissue/vasculature to provide unrestricted access for the delivery of therapeutic devices. Controlled deployment technology allows for easy, one-step access procedures that can potentially reduce vascular/tissue trauma and eliminate the need for other preoperative steps such as vascular stenting. By eliminating a number of surgical maneuvers, it may also reduce procedure time, surgical expense, and patient recovery time.