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Onset Medical Receives US FDA Marketing Clearance for Additional Size Applications for the SoloPath(TM) Endovascular Access Catheter


8/10/2010 10:48:29 AM

IRVINE, Calif.--(BUSINESS WIRE)--Onset Medical Corporation announced today the Company has received U.S. FDA 510(k) marketing clearance for new access applications of the Company’s SoloPathTM TransFemoral Endovascular Access Catheter. With this FDA marketing clearance, Onset believes that SoloPath now offers a complete line of products for access to the larger vascular anatomy with designs that provide a significantly superior method of accessing these larger vessels.

Onset’s SoloPath Endovascular Access Catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Therefore, the SoloPath may help broaden the number of patients who can be effectively treated percutaneously with femoral/iliac artery stent grafts, aortic stent grafts and new technology such as the percutaneous aortic heart valves that are now marketed in Europe and under clinical study in the U.S.

Commenting on this key regulatory approval, Onset Chief Executive Officer, Joseph Bishop said, “SoloPath is an enabling platform in that it can establish a repeatable and predictable method of access where other devices cannot, thus providing the potential for a larger patient population to be successfully treated. While many companies provide access products for the delivery of smaller therapeutic devices, we believe that Onset is in a unique position to provide access for the delivery of larger therapeutic devices such as AAA stent grafts, percutaneous delivered aortic heart valves, percutaneous mitral valve repair devices and cardiac assist products.”

A major clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treatment of aortic aneurysms (AAA stent grafts). These stent grafts require 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 $400 million and growing 20% per year. SoloPath provides significant clinical advantages in the delivery of these stent grafts. Such stent grafts are marketed by Medtronic, Gore and Cook.

The Controlled Deployment Technology Platform

The SoloPath Endovascular Access Catheter uses Onsets’ 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. Early studies indicate that this Controlled Deployment Technology can allow the physician to perform 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 has a strong intellectual property foundation including both issued patents and numerous patents pending surrounding the SoloPath Access Technology.

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.

Contacts For Onset Medical Corporation Tracy Pearson, 949-581-7250, ext. 112



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