Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory steroids along with 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.
“This is a very important milestone for the company. There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results 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 our micro-infusion technology can place drug directly where it is needed and will have a strong benefit,” CEO Trent Reutiman said in a press release.
The 1st patient in the trial was treated at Bad Krozingen, Germany’s University Heart Center, and the trial is slated to enroll a total of up to 120 patients in the coming months.
“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 critical limb ischemia. We aim to show with this trial that the therapy can improve the outcomes in this desperate condition,” principal investigator Dr. Dierk Scheinert of the University hospital of Leipzig said in prepared remarks.
Mercator said it also plans to run a U.S. study, the Limbo-ATX, which will combine the therapy with atherectomy, which utilizes catheters with cutting blades or spinning surfaces to remove plaque from arteries.
The company said it has already submitted plans for this trial to the FDA.