Advanced Catheter Therapies, Inc. (ACT), a research and development medical device company, announced that its Occlusion Perfusion Catheter (OPC) has received its second US Food and Drug Administration (FDA) 510(k) clearance. The patented OPC is a universal targeted therapeutic agent delivery catheter.
“ACT is very excited about this second FDA 510(k) clearance for the OPC. With the additional range of sizes, ACT can now offer treatment delivery options for vessels 3mm-10mm in diameter and disease length up to 15cm in length,” said Mark Rich, VP business development for ACT.
ACT is in talks with several potential partners for the licensing rights to bring OPC forward to full commercialisation.
Earlier this year, the OPC was featured in a live case educational presentation during the 16th Annual New Cardiovascular Horizons (NCVH) Conference. Frank T. Bunch, M.D., F.A.C.C., principal investigator for the IRB-approved COPPER-A & B (The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis) clinical trials, performed the case for the educational discussion.
“We strongly feel the OPC, which has a growing intellectual property estate and strong patent protection, is positioned to be the next generation of therapeutic agent delivery devices,” said Paul Fitzpatrick, CEO for ACT.
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 localised 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.
ACT operates as a highly efficient research and development organisation, developing its product line through a phased approach. The company’s role in product development includes design, engineering, prototype development and patent filing. In addition, ACT can move forward human clinical trials, regulatory approval and initial market development. “We are focused on innovation and out-license or sale of each device technology to a strategic partner,” said Fitzpatrick.