Mercator MedSystems touted data today from its Dance clinical trial evaluating the company’s Bullfrog micro-infusion device as a delivery system for a generic anti-inflammatory steroid, dexamethasome. Mercator’s results were presented at the International Symposium on Endovascular Therapy and Leipzig Interventional Course.
The steroid was delivered to tissues around femoropopliteal arteries after patients underwent endovascular intervention to forcibly open obstructions, the Emeryville, Calif.-based company said.
The Bullfrog micro-infusion device is FDA 510(k)-cleared and CE-Marked. It was designed to deliver therapeutic and diagnostic agents directly and non-systemically through blood vessel walls into adventitial tissues. The device is tipped with a balloon-sheathed microneedle, which can target vessels 2 to 8 millimeters in diameter.
The 13-month data from the clinical trial were separated int0 2 groups, based upon the method of revascularization – artherectomy or angioplasty without artherectomy.
Both groups experienced no post-operative deaths within 30 days. Major adverse limb events prior to revascularization was reported as 1.6% in the atherectomy group and 0.9% in the angioplasty group.
Primary patency, defined as the lack of clinically-driven target lesion revascularization, was 88.7% for the atherectomy group and 89.1% in the angioplasty group at 13 months.
“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,” co-principal investigator Dr. Mahmood Razavi said in prepared remarks. “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 successful outcomes from the DANCE trial validate the efficient and precise capability of a micro-infusion approach using the Bullfrog device,” Mercator CEO Trent Reutiman added. “We believe that this represents the first of many potential applications utilizing the Bullfrog for targeted drug delivery with direct visualization.”