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ACT obtains FDA 510(k) approval for Occlusion Perfusion Catheter

Advanced Catheter Therapies (ACT), a US-based developer of medical devices, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Occlusion Perfusion 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 multi-lumen balloon catheter is capable of creating 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.

Occlusion Perfusion Catheter has a greater capability of measuring pressure applied inside the treatment chamber and its inflow and outflow ports for chamber evacuation, filling and flushing.

ACT CEO Paul J Fitzpatrick noted the company is very excited about the FDA 510(k) approval for the OPC.

"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," Fitzpatrick added.

The device affords clinicians the ability to select the treatment agent and volume along with significantly limiting systemic release of the treatment agent.