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# Biotronik Breakthrough Status for Freesolve Device
- URL: https://www.fdaweb.com/biotronik-breakthrough-status-for-freesolve-device/
- Published: 2024-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:25:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156578

FDA has granted Biotronik a beakthrough device designation for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold, intended for use in individuals suffering from chronic limb-threatening ischemia, which the company describes as the most severe form of peripheral arterial disease. The device relies on the design of the company’s Freesolve RMS for coronary artery lesions, and is based on its BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology, according to the company. “These characteristics of the Freesolve RMS may be of particular value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free,” it says.