Additional Sizes Cleared for ACT's Occlusion Perfusion Catheter

September 23, 2015—Advanced Catheter Therapies, Inc. (ACT) announced that its Occlusion Perfusion Catheter (OPC) has received its second US Food and Drug Administration (FDA) 510(k) clearance. The OPC is a universal targeted therapeutic agent delivery catheter. The clearance is for an additional range of sizes. The delivery options for the OPC now allow treatment of vessels of 3 to 10 mm in diameter with disease length up to 15 cm. The company intends to bring the OPC to full commercialization through a strategic partner with licensing rights.

According to ACT, the OPC 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 vasculature. The device creates 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 can measure pressure applied inside the treatment chamber and its inflow and outflow ports for chamber evacuation, filling, and flushing. It allows substantial procedural control and the ability to select the treatment agent and volume along with significantly limiting systemic release of the treatment agent, stated the company.

ACT advised that eventually it will seek an indication for delivery in the coronary vasculature.