Platform

The Bullfrog® Micro-Infusion Device is available for use in the U.S. and Europe, holding 510(k) clearance and CE marking. The “Small” treats 2-4 mm diameter, the “Medium” treats 3-6 mm diameter, the “Large” treats 4-8 mm diameter, and the “Plus” treats 6-16 mm diameter vessels.

Labeling in U.S.: For Bullfrog devices capable of treating <6 mm diameter vessels – 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, or intraluminally. For Bullfrog devices capable only of treating ≥6 mm diameter vessels – In selective areas of peripheral vessels, the Bullfrog Micro-InfusionDevice is intended for infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.

Labeling in 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.

*Devices capable only of treating ≥6 mm diameter vessels are only indicated for use in peripheral vessels.