News | Peripheral Artery Disease (PAD) | October 07, 2016

First Large-Scale Trial of Bullfrog Micro-Infusion Device Shows Positive Results

Patency can be achieved if local inflammation created by atherectomy or angioplasty is controlled with a generic steroid

Mercator MedSystems, Bullfrog Micro-Infusion Device, DANCE trial, VIVA 2016, 13-month results

October 7, 2016 — Mercator MedSystems recently announced that 13-month data from the DANCE trial was presented during a late-breaking scientific session at the Vascular Interventional Advances (VIVA) Annual Conference 2016. DANCE is a prospective, multicenter, single-arm study designed to assess the clinical performance of the localized delivery of a generic steroid, dexamethasone, to the tissues around arteries that have been injured during endovascular interventions, using Mercator’s proprietary Bullfrog Micro-Infusion Device.

The data was presented by Christopher Owens, M.D., MSc, associate professor of surgery in the Division of Vascular and Endovascular Surgery at the University of California, San Francisco (UCSF).

Thirteen-month results from 281 patients that received the local dexamethasone therapy were presented. Data were separated into two treatment populations: the complete data set for 157 patients undergoing atherectomy as their primary therapy; and interim data for 124 patients undergoing angioplasty as the primary therapy. For the atherectomy group, the primary safety endpoint revealed no post-operative death and 2.4 percent major adverse limb events, and the primary efficacy endpoint of primary patency was 83.8 percent at 12 months and 80.2 percent at 13 months. Primary patency was defined as the lack of target lesion revascularization (TLR) or narrowing detected by a duplex ultrasound peak systolic velocity ratio (PSVR) greater than 2.4. Freedom from TLR was 89.7 percent at 12 months and 88.8 percent at 13 months in the atherectomy group.

According to 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.”

The data presented by Owens compares favorably to published data on drug-coated balloons (DCBs), which are expected to be used in 22 percent of peripheral cases in 2017, according to a survey conducted by RBC Capital Markets. “What we have accomplished with this study is dramatically different from prior drug delivery in the periphery,” noted Owens. “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 Mercator Bullfrog Micro-Infusion Device is a U.S. Food and Drug Administration (FDA) 510(k)-cleared and CE-Marked system designed to infuse therapeutic and diagnostic agents directly, non-systemically and safely through blood vessel walls into adventitial tissues. The device is tipped with a balloon-sheathed microneedle, and is compatible with 0.014” guide wires and 5 to 7 Fr introducer sheaths. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection needle as it is guided safely through the vasculature to target vessels with diameters of 2 to 8 mm.

The use of a microneedle to pinpoint local drug delivery has many advantages over current drug delivery technology, according to Mercator Chief Science and Technology Officer Kirk Seward, Ph.D. 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.

Seward also noted that the company is 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.

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