Elixir Medical's DynamX BTK System Receives FDA Breakthrough Device Designation for Chronic Limb-Threatening Ischemia
• Elixir Medical's DynamX BTK System receives FDA Breakthrough Device Designation for treating below-the-knee arterial disease in chronic limb-threatening ischemia (CLTI) patients.
• The DynamX Bioadaptor platform aims to restore vessel function by providing dynamic support during healing and maintaining an open lumen in affected vessels.
• The breakthrough designation expedites the review process, acknowledging the technology's potential to address unmet needs in treating severe peripheral arterial disease.
• Clinical data has demonstrated the Bioadaptor's ability to achieve high acute lumen gain and restore vessel motion, potentially improving outcomes in BTK revascularization.
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