Advanced Catheter Therapies said today it won a 2nd FDA 510(k) for its Occlusion Perfusion catheter, covering a new range of sizes for the device.
The OPC is a multi-lumen balloon catheter designed to occlude vessels for the local delivery of therapeutic agents, the Chattanooga, Tenn.-based company said.
“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 aup to 15cm in length,” business development veep Mark Rich said in a press release.
The catheter is designed to measure pressure applied inside the treatment area and allows for inflow and outflow for chamber evacuation, filling or flushing, ACT said.
“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,” CEO Paul Fitzpatrick said in prepared remarks. “We are focused on innovation and out-license or sale of each device technology to a strategic partner.”
ACT said they are discussing options to commercialize the device with “several potential partners.”