Mercator MedSystems has announced their first patient enrollment from Bad Krozingen, Germany, in the company's LIMBO-PTA clinical trial. This trial combines localized drug delivery using the company's proprietary Bullfrog® Micro-Infusion Device of an off-the-shelf anti-inflammatory steroid (dexamethasone) with angioplasty.
The study measures the benefit of adding drug delivery to the catheter-based re-opening of arteries below the knee in patients suffering from critical limb ischemia (CLI).
In vessels below the knee, while balloon angioplasty is able to open the clogged artery, a scarring process usually leads to re-obstruction of the vessel within 6 months of the procedure. The purpose of locally delivering an inexpensive generic anti-inflammatory drug to the vessel is to extinguish the biological signals that cause the buildup of scar tissue and lead to restenosis.
Two CLI trials are planned by Mercator, both of which are randomized, controlled trials: the German study (LIMBO-PTA), which pairs the therapy with angioplasty, and a United States study (LIMBO-ATX) which combines the therapy with atherectomy and has been submitted to the FDA. In angioplasty procedures, a high-pressure balloon is used to compress plaque and force the artery open, while atherectomy utilizes catheters with cutting blades or rough spinning surfaces to physically remove plaque from the artery.
Both of these procedures are well known to cause blood vessel inflammation that leads to the re-occlusive scarring process.
The first patient in the LIMBO-PTA trial was treated by Dr. Elias Noory at the University Heart Center in Bad Krozingen, Germany. A total of up to 120 patients are intended to be enrolled over the coming months. Prof. Dr. Dierk Scheinert, Head Department of Interventional Angiology, University Hospital of Leipzig and the Principal Investigator of the trial, 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 critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."
Trent Reutiman, the CEO of Mercator, noted, "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."