Healthcare Industry News:  Edwards Lifesciences 

Devices Interventional Cardiology

 News Release - October 27, 2009

Onset Medical Performs First Human Use of the SoloPath Endovascular Access Catheter to Deliver Percutaneous Aortic Heart Valve

IRVINE, Calif.--(HSMN NewsFeed)--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.”

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. 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 and expects to launch the SoloPath in early 2010. Numerous patents surrounding the SoloPath Access Technology are pending.

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 applications including in coronary, neurovascular, gastrointestinal and urological procedures.


Source: Onset Medical

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