Elixir Medical Receives FDA Breakthrough Device Designation

Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease

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 company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease.

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Motasim Sirhan , Drug Administration , Elixir Medical , Breakthrough Device Designation , Dynamx Bioadaptor , Device Designation , United Kingdom ,

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