A Medical Device Daily

Onset Medical (Irvine, California) reported that the company has received CE mark approval to begin marketing the company's SoloPath Endovascular Access Catheter in the European Union.

The primary clinical applications for the SoloPath 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 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 (Irvine, California) and Medtronic (Minneapolis). 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 about $300 million and growing 25% per year. The SoloPath will provide significant clinical advantages in the delivery of these stent grafts.

The SoloPath 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 about 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 CDT 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 which are often required for access with conventional devices, the company said.

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.

"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," said Onset CEO, Joseph Bishop. "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."

Synexus moves into new UK headquarters

Synexus (Manchester, UK) reported that it has doubled its head office capacity as it continues to enjoy strong growth across the UK Central and Eastern Europe, India and South Africa. The move into the new, modern head office premises, includes taking over an adjacent building and completely re-vamping the existing offices. Part of the re-modeling process has involved the installation of a state-of-the-art Cognos IT system which was developed in partnership with IBM and promises to deliver significant benefits to Synexus clients right across the clinical study lifecycle.

The head office, from which Synexus manages its global network of 16 dedicated research centers, now employs some 60 staff who have helped increase the company's turnover by 60% in 2008 and are forecasting a similar increase in 2009.

Synexus said it is also developing its presence in Central and Eastern Europe with a recently opened regional office in Hungary headed up by Christian Tueni. Synexus already has sites in Poland, Hungary and Bulgaria with several more planned.

Synexus is devoted to the recruitment of clinical trials at its own dedicated research centers across the globe on behalf of its pharmaceutical, biotech and CRO clients.