FDA Clears Advanced Catheter Therapies' Occlusion Perfusion Catheter

October 8, 2013—Advanced Catheter Therapies, Inc. (ACT, Chattanooga, TN) announced that its Occlusion Perfusion Catheter (OPC) has received US Food and Drug Administration 510(k) clearance. ACT, which is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis, stated that it is seeking a partner to move the device toward full commercialization.

According to ACT, the OPC device is a multilumen 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 company noted that the OPC is able to measure pressure applied inside the treatment chamber and its inflow and outflow ports for chamber evacuation, filling, and flushing. The device provides substantial procedural control and the ability to select the treatment agent and volume along with significantly limiting systemic release of the treatment agent.