Onset Medical announces first clinical usage of its Solopath Endovascular Access Catheter

Onset Medical Corporation announced today the first human usage of its SoloPath^TM Endovascular Access Catheter in a case performed by Eberhard Grube MD, Chief, Department of Cardiology/Angiology, Helios Heart Center, Siegburg in Germany.

The primary clinical applications for the SoloPath family of Endovascular Access Catheters are to provide quicker and safer access of larger therapeutic devices through the femoral and iliac arteries of the leg into the larger aortic artery. For example, it is estimated as many as twenty percent (20%) of patients who require replacement aortic heart valves have severe atherosclerotic disease in their leg arteries which may prevent access. This limits the use of newer percutaneous aortic valves being marketed in Europe by Edwards Lifesciences and Medtronic. In these patients, the valve has to be delivered either through a minimally invasive incision near the heart or via a totally open heart surgical procedure. Onset’s SoloPath is designed to provide access to these diseased arteries at 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.

Commenting on this first clinical usage, Dr. Grube said, “I was pleased with Onset Medical's SoloPath Endovascular Catheter. It provided easy, safe and reliable access through the femoral and iliac artery of an 85 year old patient while enabling unrestricted delivery of a percutaneous valve system.”

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. They are implanted minimally invasively as a substitute for conventional open surgical procedures to treat ruptured aneurysms. The annual market for such stent grafts is approximately $300 million and growing 25% per year. The SoloPath will provide significant clinical advantages in the delivery of these stent grafts. Such stent grafts are marketed by Medtronic, Gore, Cook and Endologix.

Onset Chief Executive Officer, Joseph Bishop, said, “This first case demonstrates that the SoloPath Catheter will provide surgeons and cardiologists with an important new tool for faster, safer and easier delivery of larger therapeutic devices, such as percutaneous aortic heart valves and minimally invasive aortic aneurysm stent graft devices. We are preparing a market launch of the SoloPath Endovascular Catheters in early 2010.”