BIOTRONIK's Freesolve™ Below-the-Knee Resorbable Magnesium Scaffold Receives FDA's Breakthrough Device Designation

Friday, March 22, 2024

BIOTRONIK has achieved Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its Freesolve™ below-the-knee resorbable magnesium scaffold (BTK RMS). This innovative device is specifically designed to address chronic limb-threatening ischemia (CLTI), the most severe form of peripheral arterial disease (PAD), which affects millions globally and is associated with high rates of amputation, mortality, and healthcare costs.

The BDD designation signifies that the Freesolve BTK RMS has the potential to significantly improve treatment outcomes for life-threatening diseases or debilitating conditions like CLTI. It accelerates the device's development, evaluation, and review processes while ensuring regulatory standards are met.

BIOTRONIK's Freesolve RMS for coronary artery lesions, featuring the BIOmag® magnesium alloy and Orsiro® drug-eluting stent (DES) coating technology, offers enhanced safety, deliverability, and vessel support. It has demonstrated impressive magnesium degradation after 12 months in coronary arteries, making it a promising option for BTK interventions where temporary vessel scaffolding is required.

This BDD designation for the Freesolve RMS represents a significant advancement in CLTI treatment options. It underscores BIOTRONIK's commitment to addressing physicians' needs and improving outcomes for patients with CLTI through innovative medical technologies.


Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare Innovation & Transformation SummitHealthcare CNO SummitHealthcare CMO SummitThe Healthcare Patient Experience & Engagement Summit 2024