Advanced Catheter Therapies Receives FDA Clearance for Occlusion Perfusion Catheter

Advanced Catheter Therapies Inc. (ACT) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Occlusion Perfusion Catheter (OPC).

“ACT is very excited about the FDA 510(k) approval for the OPC,” said Paul J. Fitzpatrick, CEO of ACT. “It marks an advance for ACT and our lead product, and we look forward finding a partner to move the OPC forward to full commercialization. We strongly feel the OPC, which has strong intellectual property and patent protection, is positioned to be the next generation of therapeutic agent delivery devices.”

The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the local delivery of therapeutic agents to the peripheral and eventually the coronary vasculature. The device has the ability to create a localized treatment chamber for the delivery of various types of therapeutic agents to treat a variety of disease states and place the agent circumferentially into the vasculature of the treatment chamber.

The OPC is unique in its ability to measure pressure applied inside the treatment chamber and its inflow and outflow ports for chamber evacuation, filling and flushing. It affords clinicians substantial procedural control and the ability to select the treatment agent and volume along with significantly limiting systemic release of the treatment agent.

ACT is hoping to raise $3 million in Series B preferred equity financing this year. In 2011, the company raised a total of $2.98 million in Series A equity financing through an investment consortium in Chattanooga, Tenn.

Based in Chattanooga, Tenn., Advanced Catheter Therapies is a medical device company that develops vascular disease treatment technologies, including therapies for thrombosis, inflammation, occlusions and restenosis.