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FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)

DAIC

CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. Updated estimates for the burden of chronic limb-threatening ischemia in the Medicare population, Journal of Vascular Surgery, Volume 77, Issue 6, 2023, 1760-1775 2 Seguchi M.,

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Elixir Medical Granted FDA Breakthrough Device Designation for DynamX Bioadaptor

DAIC

However, the data with the ‘leave nothing behind’ approach with bioresorbable scaffold technologies, showed non-plateauing event rates continue to occur even after resorption of the scaffold, so we needed a more innovative approach to restore vessel viability,” said Motasim Sirhan, CEO of Elixir Medical.

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HeartFlow Announces Revolutionary Five-Year Data Demonstrating a 63 Percent Mortality Reduction with FFRCT-Guided Care in PAD Patients

DAIC

The 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS).” Longitudinal assessment of safety of FEMOROPOPLITEAL endovascular treatment with paclitaxel-coated devices among Medicare beneficiaries.” 2024, [link].