Advanced Catheter Therapies Receives FDA 510(k) Clearance on Occlusion Perfusion Catheter
Advanced Catheter Therapies Inc. (ACT) officials announce that its Occlusion Perfusion Catheter (OPC) received U.S. Food and Drug Administration (FDA) 510(k) clearance. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.
“ACT is very excited about the FDA 510(k) approval for the OPC,” states 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.”
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.
Source: Advanced Catheter Therapies