Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease
March 27, 2024 — Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions, according to a written statement on the designation. It is the only metallic device designed to support the vessel during the healing phase, after which it unlocks and “uncages” the vessel while providing the essential dynamic support, to restore vessel function and maintain an open lumen. Peripheral arterial disease (PAD) affects more than 200 million people worldwide.1,2 Its most severe form is CLTI, which represents an advanced stage of PAD with risk to both life and limb, and one-year estimates of mortality over 20% across a r