Onset Medical Receives U.S. FDA Marketing Clearance For The SoloPath™ TransFemoral Endovascular Access Catheter

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 10 Nov 2009 - 6:00 PST

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Onset Medical Corporation announced today the Company has received U.S. FDA 510(k) marketing clearance for the Company's SoloPath™ TransFemoral Endovascular Access Catheter.

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 grants 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, while, potentially, reducing patient contraindications and enabling a larger patient population. We plan initial usage of the SoloPath Endovascular Access Catheter in a select group of top hospitals to further prove the clinical superiority of the SoloPath versus current, conventional access devices, with a broader marketing launch planned for early 2010."

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. 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 numerous patents pending surrounding the SoloPath Access Technology.

Source
Onset Medical Corporation