Mercator MedSystems this week touted 13 month data for its Bullfrog micro-infusion device for the local delivery of steroids to tissues around the arteries.
The Emeryville, CA-based company collected data from 281 patients in the DANCE trial, separating them into two groups: 157 patients undergoing atherectomy as their primary therapy and 124 patients undergoing angioplasty as the primary therapy.
The trial evaluated the safety and efficacy of Mercator’s micro-infusion device. The Bullfrog micro-infusion device is an FDA 510(k)-cleared and CE-Marked system designed to infuse therapeutic and diagnostic agents directly through blood vessel walls into tissues. In the study, the micro-infusion delivered dexamethasone, a generic steroid, to tissues around the arteries that were injured during endovascular interventions.
Mercator reported no post-operative death and 2.4% major adverse limb events for the atherectomy group. Freedom from target lesion revascularization (TLR) was 89.7% at 12 months and 88.8% at 13 months in the atherectomy group.
According to Dr. Owens, “The adventitial drug delivery of dexamethasone, or ADD-DEX, procedure using the Bullfrog Micro-Infusion Device in the DANCE trial has produced promising patency, a very low TLR, and an exemplary safety and device performance record. These data, in my opinion, warrant a paradigm shift toward an anti-inflammatory and pro-resolution strategy for restenosis. The message is clear and simple: an inflammatory process, like what we know we create when we open an artery, requires an anti-inflammatory remedy,” Dr. Christopher Owens of the University of California San Francisco said.
“What we have accomplished with this study is dramatically different from prior drug delivery in the periphery,” he added. “Until now, drug-coated balloons have incorporated drugs that were designed to fight cancer. We are now showing that if we control the potent local inflammation created when we open the vessel by atherectomy or angioplasty, we can see a similar result in a more challenging cohort of patients.”
“The use of a microneedle to pinpoint local drug delivery has many advantages over current drug delivery technology. It affords the physician an opportunity to add X-ray-opaque contrast dye and create a visualization of the agent’s delivery and the ability to diagnose successful local drug administration. Micro-infusion also allows the physician to deliver varying amounts of drug through one catheter rather than a fixed amount based on the coating dimensions associated with a balloon or stent,” Mercator chief science and technology officer Kirk Seward said in prepared remarks. “Achieving these results with a straightforward, off-the-shelf, low-cost steroid gives us great enthusiasm for what might be possible with other agents. We are also encouraged with the LIMBO studies currently underway, two below-the-knee clinical trials that are using the Bullfrog Micro-Infusion Device to deliver the same drug for patency improvement in critical limb ischemia (CLI) patients.”