LimFlow Wins FDA Approval of IDE for Percutaneous Deep Vein Arterialization System
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