LIMBO-PTA Evaluates Mercator's Bullfrog Microinfusion Device to Treat CLI

January 21, 2016—Mercator MedSystems, Inc. announced commencement of enrollment in the company's LIMBO-PTA clinical trial, which is investigating the company’s Bullfrog microinfusion device for localized drug delivery of an off-the-shelf anti-inflammatory steroid (dexamethasone) combined with angioplasty. 

The study measures the benefit of adding drug delivery to the catheter-based reopening of arteries below the knee in patients with critical limb ischemia (CLI). The purpose of locally delivering an inexpensive generic anti-inflammatory drug to the vessel is to extinguish the biological signals that cause the build-up of scar tissue and lead to restenosis, noted the company.

Two CLI trials are planned by Mercator, both of which are randomized, controlled trials. The German study (LIMBO-PTA) pairs the therapy with angioplasty. The United States study (LIMBO-ATX) is designed to investigate the therapy with atherectomy. 

The first patient in the LIMBO-PTA trial was treated by Elias Noory, MD, at the University Heart Center in Bad Krozingen, Germany. A total of up to 120 patients are intended to be enrolled during the coming months. The trial’s Principal Investigator is Prof. Dierk Scheinert, MD, Head of the Department of Interventional Angiology at University Hospital of Leipzig in Germany.

In the company’s announcement, Prof. Scheinert commented, “We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with CLI. We aim to show with this trial that the therapy can improve the outcomes in this desperate condition.”