News | Peripheral Artery Disease (PAD) | February 15, 2017

Clinical Trial Data Presented from Mercator MedSystems’ DANCE Trial at ISET and LINC

First large-scale trial of Bullfrog Micro-Infusion Device with dexamethasone shows positive results

Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device

February 15, 2017 — Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented comprehensive 13-month trial data during Late-Breaking sessions at ISET (International Symposium on Endovascular Therapy) in Hollywood, Fla., and LINC (Leipzig Interventional Course) in Leipzig, Germany.

The ISET data was presented by Mahmood Razavi, M.D., and the LINC data was presented by George Adams, M.D.

Mercator MedSystems’ Bullfrog Micro-Infusion Device was used in the trial to deliver a generic anti-inflammatory steroid (dexamethasone) along with radio-opaque contrast to visualize distribution. The drug was delivered to the tissues around femoropopliteal arteries after undergoing endovascular intervention to forcibly open obstructions. The data demonstrate a high level of durability of the revascularization, low occurrence of major adverse limb events, and no device or drug-related adverse events.

“We attribute the success seen in the DANCE trial to the Bullfrog device and its ability to efficiently deliver drug in difficult-to-reach anatomy,” said Razavi. “Technologies such as drug-coated balloons or drug-eluting stents use chemotherapeutic agents to reduce the risk of scar tissue buildup inside the arteries. Alternatively, we have proposed that the delivery of an anti-inflammatory agent to the outside of the artery enhances the healing process and interrupts the cascade leading to scar formation and restenosis. Overall, we have found the therapy in DANCE to be intuitive, safe and effective.”

The 13-month data from DANCE were separated into two groups based on method of revascularization: Atherectomy was performed in 157 limbs, while 124 limbs received angioplasty without atherectomy. For both groups, the primary safety endpoint revealed no post-operative death within 30 days, with major adverse limb events prior to a revascularization reported as 1.6 percent in the atherectomy group and 0.9 percent in the angioplasty group. The per-protocol primary efficacy endpoint of primary patency did not widely vary between groups, with 83.6 percent at 12 months and 80 percent at 13 months in the atherectomy group, and 80.2 percent at 12 months and 78.2 percent at 13 months in the angioplasty group. Primary patency was defined as the lack of clinically-driven target lesion revascularization (CD-TLR) or narrowing detected by a duplex ultrasound peak systolic velocity ratio (PSVR) greater than 2.4. Freedom from CD-TLR was 89.6 percent at 12 months and 88.7 percent at 13 months in the atherectomy group, and was 89.1 percent at both 12 and 13 months in the angioplasty group. No broad disparities were reported among results by gender, with 13-month primary patency of 79.3 percent in men and 77.9 percent in women, or by diabetic status, with 13-month primary patency of 79.5 percent in diabetics vs. 78.8 percent in non-diabetics.

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-inch guide wires and 5 to 7 French 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 millimeters.

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