Mercator MedSystems announced completion of enrollment today in the company’s LIMBO-ATX (Lower-Limb Adventitial Infusion of Dexamethasone via Bullfrog to Reduce Occurrence of Restenosis after Atherectomy-Based Revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator’s proprietary Bullfrog® micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularization procedures in below-the-knee (BTK) critical limb ischemia (CLI), a debilitating vascular disease that may result in amputation and is estimated to affect 22-30 million persons worldwide. Current solutions for CLI are substandard and face many limitations, leaving a significant unmet need for these patients and physicians treating the disease.
“The investigators associated with LIMBO-ATX are very excited to have completed enrollment in this important study. Meaningful results utilizing Mercator’s proprietary delivery technique could lead to a change in the standard of care treatment of CLI in the U.S.,” said Dr. George Adams, National co-Principal Investigator for LIMBO-ATX and Director of Cardiovascular and Peripheral Vascular Research at the University of North Carolina, Chapel Hill.
LIMBO-ATX is a prospective, multi-center, randomized, controlled trial that enrolled over 100 patients with arterial obstructions in their BTK arteries. Lack of blood flow through these arteries to the foot causes complications such as resting pain, non-healing wounds or tissue loss. Positive results from the study can be used by the company to seek new indications for the use of Bullfrog to deliver the generic steroid dexamethasone for patients with CLI to improve the outcomes of revascularization alone.
“The completion of enrollment in LIMBO-ATX is an important step in validating Mercator’s new therapeutic approach to treat CLI disease, and we look forward to seeing the primary 6-month endpoint data in the second quarter of 2018,” said Trent Reutiman, CEO of Mercator. “We are encouraged by our investigators’ ability to swiftly complete this study in an area where other technologies have consistently yielded little benefit or have been unable to reach the conclusion of the study.”
Mercator previously sponsored the DANCE trial, which reached its primary endpoint in early 2017 and demonstrated positive patency outcomes from delivering dexamethasone in combination with angioplasty or atherectomy in above-the-knee (ATK) endovascular revascularization.
