FDA Clears Onset's SoloPath Transfemoral Endovascular Access Catheter

November 9, 2009—Onset Medical Corporation (Irvine, CA) announced US Food and Drug Administration 510(k) marketing clearance for the company's SoloPath transfemoral endovascular access catheter. The company will conduct a limited initial launch with a broader market launch in early 2010.

According to Onset, the SoloPath endovascular access catheters are designed to provide access to diseased arteries at a relatively small catheter size and then to be expanded to provide a conduit for the delivery of larger diameter devices. This design may help broaden the number of patients who can be effectively treated percutaneously with femoral/iliac artery stent grafts, aortic stent grants, and new technologies such as the percutaneous aortic heart valves. Another clinical application for the SoloPath catheter is in the delivery of stent grafts for the treatment of aortic aneurysms.

The SoloPath endovascular access catheter uses Onset's controlled deployment technology. The catheter enters the body at approximately one-half the diameter of conventional access sheaths, is very flexible, and provides superior navigation through the vascular anatomy. Once in position, the device is deployed using radial expansion to expand the sheath and remodel the tissue/vasculature in order to provide unrestricted access for the delivery of therapeutic devices. The SoloPath may reduce procedural time, surgical expense, and patient recovery time, the company stated.