Chattanooga’s ACT receives second FDA 510(k) clearance
Advanced Catheter Therapies Receives Second FDA 510(k) Clearance on Occlusion Perfusion Catheter
CHATTANOOGA, TN, September 23, 2015 – Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) today announced that its Occlusion Perfusion Catheter™ (OPC) has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The patented OPC is a universal targeted therapeutic agent delivery catheter. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting peripheral vascular disease.
“ACT is very excited about this second FDA 510(k) clearance for the OPC,” said Mark Rich, VP Business Development for ACT. “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.” ACT is in talks with several potential partners for the licensing rights to bring OPC forward to full commercialization.
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.