The Mercator Bullfrog® Micro-Infusion Device is a system designed to inject therapeutic 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 - 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 2-8 mm. When the desired injection site is reached, the balloon is inflated to 2 atmospheres with saline and radio-opaque contrast, securing the system for injection and sliding the microneedle through the vessel wall. This low pressure inflation does not cause trauma to the vessel wall, unlike standard angioplasty balloons that operate at 8-20 atmospheres.
The Bullfrog device has received 510(k) marketing clearance from the U.S. Food and Drug Administration and is CE Marked.
510(k) Indications for Use (USA): In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall, perivascular area, or intraluminally. (08/16)
CE Mark Indications for Use (Europe): In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall or perivascular area, including local-acting anti-inflammatory agents to treat local inflammation. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally. The Bullfrog Micro-Infusion Device is indicated for the infusion of anti-inflammatory agents such as dexamethasone sodium phosphate to reduce vascular inflammation associated with endovascular revascularization. (02/16)