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Onset Medical Receives European CE Mark Approval for the SoloPath Endovascular Access Catheter to Deliver Percutaneous Aortic Heart Valves and Other Large Diameter Endovascular Devices



7/28/2009 8:31:37 AM

IRVINE, Calif.--(BUSINESS WIRE)--Onset Medical Corporation announced today the Company has received CE Mark approval to begin marketing the Company’s SoloPathTM 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 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 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% 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.

The Controlled Deployment Technology Platform

The SoloPath Endovascular Access Catheter uses Onset’s Controlled Deployment Technology (“CDT”) in a new and different 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, is very flexible and provides superior navigation through the vascular anatomy. 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 that this Controlled Deployment Technology can allow the physician to achieve an easy, one-step access procedure which can potentially reduce vascular/tissue trauma and virtually eliminate the need for other pre-operative steps (e.g., vascular stenting) which 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 multi-center 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.

Commenting on this CE Mark, Onset Chief Executive Officer, Joseph Bishop said, “We are pleased that the European Union has provided Onset with the go-ahead to market the SoloPath device. Our primary goal is to prove that this access approach is clinically superior to the current method of obtaining access to the endovascular system. Our early experience indicates that the SoloPath will provide surgeons and cardiologists with an important new tool for the delivery of larger therapeutic devices, such as percutaneous aortic heart valves and minimally invasive aortic aneurysm stent graft devices. In addition, we believe this approach to access can be applied to various clinical settings, thus providing broad clinical and market applications for Onset Access Technology. We are actively investigating the use of our technology in percutaneous coronary, gastrointestinal and urological procedures.”

Onset Medical Corporation is a private medical technology firm located in Irvine, California. Onset is developing the Company’s Controlled Deployment Technology to provide clinically superior minimally invasive and percutaneous access for a wide range of medical procedures.

Contact:

For Onset Medical CorporationTracy Pearson949-581-7250, ext. 112


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