First double-blind randomized controlled trial in the United States to date of unmet need in critical limb ischemia
SAN LEANDRO, Calif. /ACCESSWIRE/November 3, 2022/ Mercator MedSystems, Inc. (“Mercator”), a medical technology company specializing in local drug delivery, today announced that data from the Phase 2 TANGO (Temsirolimus adventitial delivery to Improve ANGiographic Outcomes below the knee) were published in the Journal of Endovascular Therapy (https://doi.org/10.1177/15266028221131459). The trial investigated local administration of a rapamycin analog (temsirolimus) to tissues around arteries with the aim of reducing symptomatic re-obstruction of atherosclerotic arteries below the knee after catheter procedures were used to open the vessels and restore blood flow to the foot. The drug was delivered through Mercator’s Bullfrog micro-infusion device, an FDA-approved product with a microscopic sheathed needle design that, upon inflation of a balloon at the end of the device, drags the micro -needle through the blood vessel wall to deposit the drug into the adventitia, a biologically rich tissue where active cells are known to spread during the process of vessel healing.
In patients with lower leg atherosclerosis, catheter-based procedures to restore blood flow typically involve balloon angioplasty, which opens the artery by displacing obstructions using a high-pressure balloon , or an atherectomy, which physically alters the obstructions by laser, micro-cutters, or micro-grinding surfaces. However, approximately half of these treatment results are not long-lasting, with pain or other symptoms due to reobstruction returning within 6 months of mechanical intervention. Durability of interventional procedures remains a great unmet need in critical limb ischemia and especially for below-knee interventions.
Results from the TANGO clinical trial were positive, as measured by failure of the clinically relevant target lesion, composite of symptomatic reobstruction, or need for an additional procedure to reopen the artery within the first 6 months after the procedure initial. This failure rate was reduced by a relative percentage of 51.3% between trial participants receiving a sham injection of placebo and those receiving the active drug. A measurement of side-view open artery area by x-ray also demonstrated beneficial trends 6 months after the initial procedure, in which the amount of arterial side-view area lost in the first 6 months was 37, 3% lower, relatively, in treatment patients compared to controls. Importantly, this was the first trial of local drug treatment for small arteries below the knee in the United States to report positive double-blind, randomized, controlled data. The use of double-blinding in clinical trials is important to eliminate biases inherent in the analysis of patient outcomes and is used to increase the robustness of clinical signals.
Ken Ouriel, MD, MBA, the manuscript’s corresponding author and NAMSA/Syntactx Medical Director, noted, “The TANGO trial represents significant Level 1 evidence supporting the efficacy of drug delivery in stenotic arteries. and occluded – lesions that have historically been difficult to treat and maintain long-term patency. The efficiency with which the drug was delivered into the vessel wall in this study is a likely factor in the greater success observed compared to other technologies. I’m excited to see this technology continue through testing towards eventual regulatory approval.”
The TANGO study was designed and funded by Mercator, with additional funding from grants provided by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Kirk Seward, PhD, President and Chief Science and Technology Officer of Mercator and Principal Investigator of the NIH grant, added, “The release of this data is an important milestone for Mercator as we continue our efforts to optimize treatment strategies for patients. suffering from debilitating pain and ischemia in their legs. As we move this program forward into a Phase 3 trial and seek FDA approvals, we have positive data to inform our decisions and guide our research design. We look forward to the potential ability to help many more patients down the road.”
The research reported in the publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number R44HL102998. The content is the sole responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About the Bullfrog® Micro-Infusion Device
The Bullfrog micro-infusion device is FDA cleared and CE marked. The device includes a balloon that hydraulically deploys a microneedle through the vessel wall into perivascular tissue, where the needle can then effectively infuse drugs or biologics around an artery or vein. Drug delivery through the Bullfrog is monitored with X-ray contrast agents, allowing precision therapy to local tissues with visual feedback to the physician using the device.
About Mercator MedSystems, Inc.
Mercator is a medical technology company focused on the clinical and commercial development of proprietary, FDA-cleared, CE-marked micro-infusion technologies, including the Bullfrog® micro-infusion device for the local delivery of therapeutic products in blood vessels and the Blowfish ® Transbronchial micro-infusion catheter for placement in the airways. Mercator is developing clinical applications in peripheral vascular disease, cancer, hypertension and cardiac regeneration. For more information, visit www.mercatormed.com.
Chief executive officer
Mercator MedSystems, Inc.
520 McCormick Street
San Leandro, California 94577
Email: [email protected]
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