LimFlow On Target For 2021 US Launch Of Deep Vein Arterialization System

The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.

Lim Flow Crossings Stent Deploy Full
The LimFlow system diverts blood from the diseased artery into the tibial vein • Source: LimFlow, Inc.

LimFlow, Inc. expects the US Food and Drug Administration will approve its percutaneous deep vein arterialization system for patients with advanced critical limb ischemia by the end of 2021.

The LimFlow system installs a stent graft that creates an arteriovenous fistula that moves blood from the diseased tibial artery into the tibial vein to revascularize the patient’s leg below the knee. The system earned a CE mark in 2016 and is available in Europe

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