FDA Clearance for Novel 5 Lumen Occlusion Perfusion Catheter

Chattanooga vascular device specialist Advanced Catheter Therapies, Inc. (ACT), has gained FDA clearance for its clever multi-lumen Occlusion Perfusion Catheter™ (OPC). ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.

Background

The OPC is 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 uniqueness of the OPC stems from its ability to measure pressure applied inside the treatment chamber and its inflow and outflow ports for chamber evacuation, filling and flushing. This means the clinician has substantial procedural control and the ability to select the treatment agent and volume along with significantly limiting systemic release of the treatment agent.

For a nice video showing the procedural stages when using the OPC, click here.

Company comments

“ACT is very excited about the FDA 510(k) approval for the OPC,” said Paul J. Fitzpatrick, CEO of ACT. “It marks a significant 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.”