News | July 28, 2009

Onset Medical Gains CE Mark for SoloPath Catheter to Deliver Percutaneous Aortic Heart Valve

July 28, 2009 – Onset Medical Corporation said today it received CE mark approval to begin marketing the SoloPath Endovascular Access Catheter in the European Union.

The primary clinical applications for the SoloPath Endovascular Access Catheter will be to provide quicker and safer access of larger therapeutic devices through the femoral and iliac arteries of the leg into the aorta. It is estimated as many as 20 percent of patients who require replacement aortic heart valves have severe atherosclerotic disease in their leg arteries which may prevent access and 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

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 percent per year. The company said 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.

The SoloPath Endovascular Access Catheter uses Onset’s Controlled Deployment Technology (CDT) in a new approach to procedures requiring minimally-invasive access to remote sites within the body. The SoloPath enters the body at approximately half the diameter of conventional access sheaths, is very flexible and provides superior navigation through the vascular anatomy, the company said. Once in position, the device is deployed utilizing radial expansion to expand the sheath and remodel the tissue/vasculature in order to provide unrestricted access for the delivery of therapeutic devices. Thus far, early studies indicate Controlled Deployment Technology can allow the physician to achieve an easy, one-step access procedure that can potentially reduce vascular/tissue trauma and virtually eliminate the need for other preoperative steps (e.g., vascular stenting) that are often required for access with conventional devices.

The SoloPath allows minimally-invasive access in a manner that is potentially less traumatic to the arterial vasculature compared to devices currently in use. By eliminating a number of surgical maneuvers, use of the SoloPath may reduce procedural time, surgical expense and patient recovery time. Onset is focusing on a multicenter study to further prove the clinical superiority of the SoloPath versus current, conventional access devices offered by a number of large medical device firms. Onset expects to launch the SoloPath during the fourth quarter 2009. Numerous patents surrounding the SoloPath Access Technology are pending.

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