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March 21, 2024
Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System
March 21, 2024—Elixir Medical announced it has been granted Breakthrough Device designation by the FDA for its DynamX BTK system, an adaptive implant for use in the treatment of narrowed or blocked vessels below the knee in patients with chronic limb-threatening ischemia.
Elixir Medical’s DynamX [Image courtesy of Elixir Medical]
According to the company, the metallic DynamX bioadaptor platform for vascular interventions is designed to support the vessel during the healing phase, after which it unlocks and “uncages” the vessel while providing dynamic support to restore vessel function and maintain an open lumen. The company also has developed the device for percutaneous coronary intervention.
Elixir Medical stated that the DynamX bioadaptor has been shown to provide high acute lumen gain in the coronary vessels and maintain such gain over time, which is a common challenge in existing below-the-knee therapies. The bioadaptor has also been shown to restore vessel motion and function, including positive adaptive remodeling, vessel pulsatility, improved vessel dynamic compliance, and increase in blood flow volume.
The DynamX BTK system is not available for sale in the United States, advised the company.
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