Mercator MedSystems said today it enrolled the 1st patient in the Limbo-ATx trial of the company’s Bullfrog micro-infusion device.
The trial is slated to enroll 120 patients and aims to explore the benefit of localized drug delivery using the company’s device in maintaining vascular health when used alongside atherectomy procedures, the company said.
“This is a very important step for Mercator. There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results from Micro-Infusion in above-knee arteries from our Dance-Pilot study and our most recent experience from our larger, 285-patient Dance trial provide us with confidence that the Bullfrog Micro-Infusion Device can efficiently deliver the drug directly where it is needed and that doing so could impact decision making in the daily treatment of critical limb ischemia,” CEO Trent Reutiman said in prepared remarks.
In the trial, the Bullfrog micro-infusion device will be used for the local delivery of anti-inflammatory steroids during artherectomy procedures to help reduce injury and inflammation, stop scar tissue buildup and maintain blood flow.
“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,” co-principal investigator Dr. George Adams of the University of North Carolina REX Hospital said in a prepared statement.
In January, Mercator launched its Limbo-PTA clinical trial, which aims to examine the use of the company’s Bullfrog micro-infusion device as it delivers anti-inflammatory steroids alongside angioplasty to treat patients with below the knee critical limb ischemia.
The Emeryville, Calif.-based company said that the purpose of adding an anti-inflammatory drug, delivered by its Bullfrog device, is to eliminate biological signals that cause scar tissue build up and can lead to restenosis. Mercator said this commonly occurs, and leads to re-obstruction in below-the-knee balloon angioplasty procedures.
The German Limbo-PTA trial is ongoing, and is slated to enroll 120 patients, the company said.
