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Onset Medical’s SoloPath Endovascular Access Catheter Receives European CE Mark

Onset Medical Corporation has received CE Mark approval to begin marketing the Company’s SoloPath Endovascular Access Catheter in the European Union.

SoloPath Endovascular Access Catheter’s primary clinical applications 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. SoloPath is designed to provide access to the diseased arteries at a relatively small catheter size and then be expanded to accommodate the large diameter of percutaneous valve delivery devices. Hence it helps broaden the number of patients who can be effectively treated with percutaneously implanted aortic heart valves.

The SoloPath catheter uses Onset’s Controlled Deployment Technology (“CDT”) in a different approach to procedures that require minimally invasive access to remote sites within the body. The SoloPath enters the body at nearly one-half the diameter of conventional access sheaths. It is very flexible and provides superior navigation through the vascular anatomy. The device once in position is deployed utilizing radial expansion to expand the sheath and remodel the tissue/vasculature so as 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 a one-step access, easy procedure that can potentially reduce vascular/tissue trauma and virtually eliminate the need for other pre-operative steps (e.g., vascular stenting) that are often required for access with conventional devices.

The SoloPath minimally invasive access is potentially less traumatic to the arterial vasculature. Using SoloPath eliminates a number of surgical maneuvers and may reduce procedural time and patient recovery time. The company is focusing on a multi-center study to further prove the clinical superiority of the SoloPath versus current, conventional access devices and 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.”