Clinical Benefits

The Occlusion Perfusion Catheter™ (OPC), a universal delivery system, is a multi-lumen balloon catheter designed to temporarily occlude a specific region from blood flow and then locally deliver physician-specified diagnostic and/or therapeutic agents into the peripheral and coronary vasculature. The OPC can be repositioned for multiple treatments within the same patient.
 

Delivery of Paclitaxel

Atherosclerotic peripheral artery disease (PAD) is one of the most prevalent, morbid, and mortal diseases. Approximately 8.5 million people in the United States have PAD, including 12-20% of individuals older than age 60.1
 
It’s been well proven that paclitaxel inhibits the proliferation and migration of human arterial smooth muscle cells and haSMC proliferation. Furthermore, paclitaxel prevents neointimal formation in rabbits after balloon angioplasty, with a long-lasting effect achieved after just several minutes’ exposure time.2
 
Building upon published efficacy of paclitaxel coated balloons, Granada et al found that the observed tissue half-life of paclitaxel delivered by drug-coated balloons (DCBs) is rate limiting and relates to the slow dissolution of paclitaxel deposits from the vessel surface into arterial tissue in a time-depending fashion.3
 
Hawkins and Hennebry point out that local drug delivery has revolutionized the percutaneous treatment of coronary artery disease, raising interest in translating these successful from the coronaries to the peripheral vasculature.4 One- and two-year studies demonstrate favorable functional and clinical outcomes in patients with femoropopliteal artery disease requiring percutaneous revascularization.5,6
 

Delivery of Other Agents

Researchers are examining the use of DCBs for a range of treatments outside of delivering paclitaxel. Limus-eluting stents are dominating coronary interventions; preclinical studies have been undertaken to determine whether it is possible to achieve high and persistent sirolimus levels in the vessel wall after administration by a coated balloon.7 Other studies have looked at the potential efficacy of local delivery of other therapeutic agents.8,9
 
Thrombotic lesions pose a significant challenge for interventionalists. Thrombolysis has been utilized for many years as a primary modality for treatment of thrombotic occlusions; however, poor patient candidates and life-threatening bleeding remains a significant problem utilizing this approach.9 Delivering via a DCB allows 500 times the systemic concentration of abciximab locally when used with a DCB, allowing occlusion, containment and selective local infusion.10
 
Because the OPC is a universal delivery system, physicians and researchers have the flexibility to choose their preferred diagnostic or therapeutic agent and also to specify the delivered dosage.
 
1 Centers for Disease Control and Prevention; Division for Heart Disease and Stroke Prevention. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm. Accessed 5/22/17
 
2 Axel DI, Kunert W, Göggelmann C, et. al. Paclitaxel Inhibits Arterial Smooth Muscle Cell Proliferation and Migration In Vitro and In Vivo Using Local Drug Delivery. Circulation. 1997;96:636-645 doi: 10.1161/01.CIR.96.2.636. Article
 
3 Granada JF, Stenoien M, Buszman PP, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart 2014;1:e000117. doi:10.1136/openhrt-2014- 000117. Article
 
4 Hawkins BM, Hennebry TA. Local Paclitaxel Delivery for Treatment of Peripheral Arterial Disease. Circ Cardiovasc Interv 2011;4:297-302. Article
 
5 Sixt S, Cancino OGC, Treszl A,et al.  Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries. J Vasc Surg 2013;58:682-6. Paper
 
6 Micari A, Cioppa A, Vadalà G, et al. 2-Year Results of Paclitaxel-Eluting Balloons for Femoropopliteal Artery Disease - Evidence From a Multicenter Registry. J Am Coll Cardiol Intv 2013;6:282–9. Abstract
 
7 Clever YP, Peters D, Calisse J, et al. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016;9:e003543. DOI: 10.1161/CIRCINTERVENTIONS.115.003543. Article
 
8 Tharp DL, Wamhoff BR, Wulff H, et al. Local Delivery of the KCa3.1 Blocker, TRAM-34, Presents Acute Angioplasty-Induced Coronary Smooth Muscle Phenotypic Modulationa and Limits Stenosis. Arterioscler Thromb Vasc Biol 2008;28:1084-1089.
Article 

9 Sheiban I, Anselmino M, Moretti C, et al. Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries. Clin Res Cardiol. 2008 Dec;97(12):891-8. doi: 10.1007/s00392-008-0705-2. Abstract
 
10 Rajesh M. Dave, MD. Treatment of Complex Thrombotic Popliteal Chronic Total Occlusion using Pathway PV Jetstream or Laser Atherectomy, and Localized Delivery of Acbiximab via ClearWay RX Catheter. Cath Lab Digest, January 2009. Article