FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)
DAIC
MARCH 20, 2024
1 To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. CLTI is associated with high rates of amputation and mortality as well as high care costs.1
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