Product Focus

The Threat of Vascular Disease

The statistics from the American Heart Association for vascular disease show that 35 million or more Americans will be affected by some form of this deadly disease. Vascular disease is the narrowing or blocking of blood vessels due to the buildup of fatty plaque and/or blood clots.

All of the current treatment options, including atherectomy, thrombectomy, balloon angioplasty and various types of drug eluting and non-eluting vascular stents, have limitations and need to be more effective in clearing the blockage. In addition, these procedures actually create a controlled injury to the arterial vessel wall. This in turn causes the muscle cells of the media in the vessel wall to over proliferate and migrate, resulting in restenosis (re-blockage) of the blood vessel.

Approximately 30-40% of patients will develop restenosis in as little as six months following their treatment. This results in surgical re-intervention, increased cost and added patient risk. The problem in terms of lives and limbs lost is enormous and the cost to the U.S. healthcare system is estimated to be $475 billion dollars annually.

ACT's Innovative Approach

Advanced Catheter Therapies has initially focused its resources on the problem of restenosis and has developed the Occlusion Perfusion Catheter™ (OPC™). The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow and then locally deliver physician-specified diagnostic and/or therapeutic agents into the peripheral and coronary vasculature.

In addition to the OPC, the company is addressing the problem of vascular disease by developing leading edge technology for atherectomy, thrombectomy, and other catheter-based devices, which it believes will vastly improve the initial treatment of vascular disease.

ACT currently has seven devices in its product development pipeline, including the OPC. Each device is being designed and developed with targeted improvements over any existing device currently on the market. These design improvements could vastly advance the efficacy of the treatment of vascular disease and restenosis and address the enormous problem associated with these conditions worldwide.

Note—The OPC has received three 510(k) clearances. All other claims for products in the development pipeline have not yet been evaluated or cleared by the FDA.