News | Peripheral Artery Disease (PAD) | August 10, 2016

First Patients Enrolled in Mercator MedSystems’ U.S. Below the Knee Clinical Trial

LIMBO-ATX study will examine benefit of Mercator’s Bullfrog Micro-Infusion Device with atherectomy for critical limb ischemia patients

Mercator, Bullfrog Micro-infusion Device, below-the-knee, critical limb ischemia, CLI, LIMBO-ATX trial, first patients enrolled

August 10, 2016 — Mercator MedSystems Inc. announced the enrollment of the first critical limb ischemia (CLI) patients in the LIMBO-ATX trial, the design of which was approved by the U.S. Food and Drug Administration (FDA) under an Investigation New Drug (IND) application. The study is designed to measure the benefit of localized drug delivery using the company's proprietary Bullfrog Micro-Infusion Device in combination with opening obstructed arteries in the lower leg.

Patients were enrolled by George Adams, M.D., at the University of North Carolina REX Hospital in Raleigh, N.C., and by Jason Yoho, M.D., of the New Braunfels Cardiology Group at Guadalupe Regional Hospital in Seguin, Texas. Both enrollments were in conjunction with an atherectomy procedure

Atherectomy involves the use of intravascular catheter devices to debulk and/or modify plaque in the diseased arteries. While these devices can re-open clogged arteries, they also cause injury and inflammation in the blood vessel wall, which often leads to a re-occlusive scarring process, again limiting blood flow in the artery. The LIMBO-ATX trial involves the local delivery of an anti-inflammatory steroid in an attempt to stop this scar tissue buildup and keep blood flowing. This is similar to giving a cortisone shot into an inflamed joint. By locally extinguishing the 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.

LIMBO-ATX is Mercator’s second prospective, randomized, controlled, local drug delivery clinical trial for below-the-knee (BTK) vascular disease. The first study is ongoing in Germany and adds drug locally in combination with balloon angioplasty to BTK arteries. These LIMBO trials are designed to demonstrate that micro-infusion of drug in conjunction with the procedure to re-open the artery will provide much-needed durability, potentially delaying repeat procedures and reducing amputations. There have been struggles with the most recent technologies applied (drug-coated angioplasty balloons) in CLI, and thus there is a significant opportunity to assist these patients in providing them with a better long-term therapy.  

A total of up to 120 patients are planned to be enrolled in the LIMBO-ATX study over the coming months. Adams, national co-principal investigator of LIMBO-ATX, commented, "We are very excited to be one of the centers initiating enrollment of the LIMBO-ATX Study. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia, and we hope to show that this therapy can improve patient outcomes and prevent amputation."

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