Advanced Catheter Therapies ($ACT), the maker of a localized drug delivery system for the peripheral vasculature, is teaming with Toray Industries ($TORAY) to manufacture, market and sell ACT’s FDA-cleared Occlusion Perfusion Catheter (OPC).
The drug delivery device is a targeted therapeutic agent system designed exclusively for the field of peripheral vascular stenosis and restenosis. The company began manufacturing the OPC last year for use in supporting clinical trials and for a targeted test market release.
“Our first-in-human clinical trials have been very encouraging, and we have successfully met our milestones for safety and efficacy,” Paul Fitzpatrick, chief executive of ACT, said in a statement.
The company forecasts the global market for the treatment of peripheral arterial disease and targeted drug delivery to reach $3 billion by 2020. Terms of the global agreement were not disclosed.
The OPC received 510(k) clearance in October 2013. The single-use device creates a localized treatment chamber that prevents systemic release of various drugs selected by the physician. It contains 5 lumens and has a fiber-optic pressure sensor to monitor pressure within the treatment chamber and enable real-time adjustments.
After the catheter is placed in the correct part of the vessel via a guidewire, the balloon lumens at each end of the catheter inflate to form a treatment chamber, according to a company video. Then, the blood is evacuated from the treatment chamber using a saline solution. Next, the drug is delivered from within the catheter. Finally, the balloons are deflated and the catheter is removed from the body.