US-based medical device company Mercator MedSystems has recruited the first patient in its LIMBO-ATX trial to test the efficacy of localised drug delivery by the company’s patented Bullfrog Micro-Infusion Device to treat first critical limb ischemia (CLI).

The Bullfrog Micro-Infusion Device is designed to infuse therapeutic agents directly, non-systemically and safely through blood vessel walls into adventitial tissues.

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It features a balloon-sheathed microneedle at its top and is compatible with 0.014” guide wires and 5 – 7 Fr introducer sheaths.

"The LIMBO-ATX trial will conduct a local delivery of an anti-inflammatory steroid to eliminate scar tissue buildup and keep blood flowing."

The closed balloon covers the tiny, perpendicular-oriented injection needle which is inserted safely through the vasculature to target vessels with diameters of 2-8 mm.

After reaching the targeted site, the balloon inflates through the vasculature to target vessels with diameters of 2-8 mm sliding the microneedle through the vessel wall.

LIMBO-ATX is the second prospective, randomised, controlled clinical trial to test the effect of locally delivering the drug with balloon angioplasty to below-the-knee (BTK) arteries.

The study is planning to enroll up to 120 patients.

The LIMBO-ATX trial will conduct a local delivery of an anti-inflammatory steroid to eliminate scar tissue buildup and keep blood flowing.

A locally extinguished inflammation blocks the biologic signals that normally lead to scar tissue and vessel closure thereby keeping the vessel open for a longer period of time after the vascular procedure.

Mercator CEO Trent Reutiman said: “There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee.

“Our results from Micro-Infusion in above-knee arteries from our DANCE-Pilot study and our most recent experience from our larger, 285-patient DANCE trial provide us with confidence that the Bullfrog Micro-Infusion Device can efficiently deliver the drug directly where it is needed and that doing so could impact decision making in the daily treatment of critical limb ischemia."

The trial aims at demonstrating durability, delaying repeat procedures and minimising amputations with the micro-infusion of drug in conjunction with the procedure to re-open the artery.