Mercator MedSystems Begins LIMBO-ATX Trial for Bullfrog Microinfusion Device to Treat CLI

August 4, 2016—Mercator MedSystems, Inc. has begun enrollment in the LIMBO-ATX critical limb ischemia (CLI) trial, which is designed to measure the benefit of localized drug delivery using the company’s Bullfrog microinfusion device in combination with opening obstructed arteries in the lower leg. The LIMBO-ATX trial was approved by the US Food and Drug Administration under an investigational new drug application.

The LIMBO-ATX trial aims to enroll up to 120 patients. It involves the local delivery of an anti-inflammatory steroid in an attempt to stop scar tissue buildup and keep blood flowing after atherectomy procedures, which may cause injury and inflammation in the blood vessel wall. The therapy is similar to giving a cortisone shot into an inflamed joint. By locally extinguishing inflammation, the biologic signals that normally lead to scar tissue and vessel closure are reduced, potentially keeping the vessel open for a longer period of time after the vascular procedure.

The trial’s first patients were enrolled by George Adams, MD, of the University of North Carolina-Rex Hospital in Raleigh, North Carolina, and Jason Yoho, MD, of the New Braunfels Cardiology Group at Guadalupe Regional Hospital in Seguin, Texas. 

LIMBO-ATX is Mercator's second prospective randomized controlled clinical trial involving local drug delivery for below-the-knee vascular disease. The first study is ongoing in Germany and adds drug locally in combination with balloon angioplasty.

Mercator states that results from microinfusion treatment in above-the-knee arteries in the DANCE-Pilot study and the 285-patient DANCE trial support the Bullfrog microinfusion device's ability to efficiently deliver drug directly where it is needed, which the company believes could impact decision making in the daily treatment of CLI.