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Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

Elixir Medical's DynamX® BTK System, a novel bioadaptor platform for treating chronic limb-threatening ischemia (CLTI) in below-the-knee vessels, received FDA Breakthrough Device Designation. It uniquely supports and restores vessel function post-intervention, addressing a critical unmet need in vascular disease treatment.


Reference News

Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

Elixir Medical's DynamX® BTK System, a novel bioadaptor platform for treating chronic limb-threatening ischemia (CLTI) in below-the-knee vessels, received FDA Breakthrough Device Designation. It uniquely supports and restores vessel function post-intervention, addressing a critical unmet need in vascular disease treatment.

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