LimFlow has gained FDA approval for its investigational device exemption for a feasibility study of the LimFlow percutaneous deep vein arterialization system.

The device bypasses blocked arteries in the leg and delivers oxygenated blood to the foot.

The single-arm study will be conducted at three U.S. centers encompassing 10 end-stage critical limb ischemia patients.

The LimFlow system received a CE Mark in October 2016 and is currently available in Europe. — Cynthia Jessup