USPTO issues new patent to Onset Medical's SoloPath Catheter Sheath

Onset Medical Corporation announced today that the United States Patent Office has notified the Company a new patent has issued entitled "Expandable Transluminal Sheath." This new patent provides 24 claims surrounding Onset's fundamental Controlled Deployment Technology platform.

The Controlled Deployment Technology Platform

Controlled Deployment Technology ("CDT") uses a new and different approach to complete medical procedures requiring minimally invasive access to remote sites within the body. CDT catheters enter the body at approximately one-half the diameter of conventional access devices, are very flexible and provide superior navigation through the human anatomy. Once in position, the CDT sheath is deployed utilizing radial dilation to expand the sheath and remodel the surrounding tissue in order to provide unrestricted access for the delivery of therapeutic devices. For example, in cardiovascular and endovascular procedures, CDT allows the physician to perform an easy, one-step access that reduces vascular complications and vascular/tissue trauma while virtually eliminating the need for other pre-operative steps (e.g., angioplasty, vascular stenting) which are often required for access with conventional devices.

The Onset SoloPath Catheter Sheath

Onset has developed the SoloPath vascular access system. The SoloPath has now been used in over 800 patients in endovascular procedures such as in the delivery of both Edwards and Medtronic endovascular TAVI aortic valve implants, and the delivery of AAA stent grafts from various manufacturers. In such patients, the SoloPath allows minimally invasive access in a manner that is less traumatic to the arterial vasculature compared to devices currently in use. By eliminating a number of surgical maneuvers, use of the SoloPath reduces procedural time, surgical expense and patient recovery time. Use of the SoloPath in such patients has shown to reduce vascular complications. Studies are underway to prove that the SoloPath can allow the treatment of a broader group of patients with these newer therapeutic implants.

This newly issued patent builds on Onset's intellectual property foundation, which now includes 4 issued patents and 15 additional pending applications for access systems within the Company's CDT Platform. Commenting on this new patent, Onset CEO Joseph Bishop said, "This patent solidifies our intellectual property foundation and, along with our other issued patents and pending applications, provides us with broad protection for accessing the human body to more effectively complete therapeutic procedures."