Enrollment Completed in the LIMBO-ATX Trial of Mercator's Bullfrog Device to Treat CLI
November 2, 2017—Mercator MedSystems, Inc. announced that enrollment has been completed for the company's LIMBO-ATX clinical trial.
According to the company, the LIMBO-ATX trial was designed to use Mercator's Bullfrog microinfusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularization procedures in below-the-knee critical limb ischemia (CLI). The Bullfrog device, which has received 510(k) clearance from the US Food and Drug Administration and European CE Mark approval, infuses therapeutic and diagnostic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues.
LIMBO-ATX is a prospective, multicenter, randomized controlled trial that enrolled over 100 patients with arterial obstructions in their below-the-knee arteries. The company advised that positive results from the study can be used to seek new indications for the use of the Bullfrog device to deliver dexamethasone in CLI patients to improve the outcomes of revascularization alone.
George Adams, MD, Director of Cardiovascular and Peripheral Research at the University of North Carolina in Chapel Hill, North Carolina, serves as national Co-Principal Investigator for LIMBO-ATX. In the company's press release, Dr. Adams commented, "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 United States."
Mercator's DANCE trial, which reached its primary endpoint in early 2017, demonstrated positive patency outcomes in delivering dexamethasone in combination with angioplasty or atherectomy in above-the-knee endovascular revascularization. In February, the company announced the presentation of comprehensive 13-month data from the DANCE trial.