Occlusion Perfusion Catheter Demonstrates Superior Performance in PAD Drug Delivery

The Occlusion Perfusion Catheter (OPC), a multi-lumen balloon catheter from Advanced Catheter Therapies (ACT), has been selected by researchers for use in exploring a new treatment approach for peripheral artery disease (PAD) and restenosis. This is the first time that researchers have demonstrated the feasibility of delivering liquid sirolimus into the arterial wall.
 
Sirolimus is currently being explored as an alternative drug to paclitaxel for the treatment of PAD. To date, sirolimus has only been used as drug coatings for stents and balloons and no studies have yet demonstrated the delivery of sirolimus in liquid form.
 
“Pre-clinical investigation of liquid sirolimus for local drug delivery” appeared in Frontiers in Cardiovascular Medicine.
 
The researchers began by testing four commercially available liquid delivery devices for their ability to infuse a liquid drug (sirolimus) into the blood vessel wall. The OPC demonstrated greater drug penetration into the medial wall as compared to other devices, which was measured using fluorescence microscopy.
 
Once the OPC was selected as the delivery device, the researchers compared the use of liquid sirolimus versus balloons coated with the drug. The paper states, “Liquid sirolimus showed similar drug levels within the target tissue as compared to liquid paclitaxel, but greater than a commercially available sirolimus coated balloon. With growing concerns regarding the safety of paclitaxel-coated balloons in peripheral artery disease use, liquid delivery of sirolimus is potentially an innovative approach to treat occluding peripheral lesions.”
 
The efficacy of using the OPC for local delivery of liquid paclitaxel was previously demonstrated in a below-the-knee (BTK) study, “The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A).” Results from the multi‐center study demonstrated potential of the OPC catheter to safely and effectively treat de novo and restenotic BTK lesions. The results were deemed encouraging for local liquid delivery as an alternative approach for infrapopliteal revascularization, with the ability to treat very long or multiple lesions with a single device offering a more economical option.
 
The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the targeted delivery of various therapeutic and diagnostic agents to the peripheral vasculature. The OPC, which is disease and agent agnostic, has the ability to create a localized treatment chamber and place the agent circumferentially into the vasculature of the treatment chamber. It is unique in its ability to measure pressure applied inside the treatment chamber.
 
“The OPC affords clinicians substantial procedural control and the ability to select the treatment agent and volume while significantly limiting systemic release of the treatment agent,” ACT CEO Paul J. Fitzpatrick said. “ACT is seeking a strategic partner to develop a sirolimus combination product using the OPC as the delivery device.” 
 
Pressana OPC technology was developed by Advanced Catheter Therapies, which was first funded in 2011. The company has raised $8.87 million, with only a small percentage being non-dilutive grants. Sales to date of the Pressana OPC total $7.8 million, including licensing fees. ACT’s primary focus has been on R&D and licensing. The Pressana OPC has received three U.S. Food and Drug Administration 510(k) clearances and multiple patents.