First Large-Scale Trial of the Bullfrog Micro-Infusion Device with Dexamethasone Shows Positive Results
EMERYVILLE, Calif., Feb. 8, 2017 -- Mercator MedSystems today announced that Mahmood Razavi, MD, and George Adams, MD, the national co-Principal Investigators of the Company's DANCE trial, each presented comprehensive 13-month data from the trial during Late-Breaking sessions at ISET (International Symposium on Endovascular Therapy) in Hollywood, Florida and LINC (Leipzig Interventional Course) in Leipzig, Germany, respectively. The Company's 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 Dr. 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% in the atherectomy group and 0.9% in the angioplasty group. The per-protocol primary efficacy endpoint of primary patency did not widely vary between groups, with 83.6% at 12 months and 80.0% at 13 months in the atherectomy group, and 80.2% at 12 months and 78.2% 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% at 12 months and 88.7% at 13 months in the atherectomy group and was 89.1% 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% in men and 77.9% in women, or by diabetic status, with 13-month primary patency of 79.5% in diabetics vs. 78.8% in non-diabetics.
"The successful outcomes from the DANCE trial validate the efficient and precise capability of a micro-infusion approach using the Bullfrog device," commented Mercator Chief Executive Officer, Trent Reutiman. "We believe that this represents the first of many potential applications utilizing the Bullfrog for targeted drug delivery with direct visualization."
About the Bullfrog® Micro-Infusion Device:
The Mercator Bullfrog Micro-Infusion Device is a 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 Bullfrog device is tipped with a balloon-sheathed microneedle, and is compatible with 0.014" 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.
About the DANCE Trial:
The Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy after Femoropopliteal Revascularization (DANCE) trial is a perivascular drug delivery trial that pairs the Bullfrog Micro-Infusion Device with dexamethasone to treat femoral and popliteal arteries after revascularization. DANCE is a prospective, multicenter, single-arm study designed and sponsored by Mercator. The trial is being conducted in 35 centers and its leadership includes co-principal investigators Mahmood Razavi, MD, from St. Joseph's Hospital in Orange, California, and George Adams, MD, from the University of North Carolina-Rex Healthcare, in Raleigh, North Carolina. More information about the DANCE trial is available at https://clinicaltrials.gov/ct2/show/NCT01983449.
Mercator MedSystems, Inc. (www.mercatormed.com), based in Emeryville, CA, is a venture-backed, privately held medical technology company. The company develops proprietary catheter-guided micro-infusion systems for targeted delivery of drugs and biologics deep inside the body to treat the root cause of a growing portfolio of medical conditions, including peripheral disease, cardiovascular disease, cancer, hypertension and heart disease.
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