March 18, 2024

Biotronik’s Freesolve BTK RMS for CLTI Granted FDA Breakthrough Device Designation

March 18, 2024—Biotronik announced it has been granted FDA Breakthrough Device designation for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold (RMS), which is designed for patients with chronic limb-threatening ischemia.

Biotronik noted that the BTK RMS device shares characteristics of the Freesolve RMS for coronary artery lesions, which was recently launched in markets that accept the CE Mark.

Freesolve RMS is based on the company’s Biomag magnesium alloy and Orsiro drug-eluting stent coating technology to provide safety, improved deliverability, optimal performance, and vessel support during and after implantation. It has shown 99.6% degradation of magnesium observed at 12 months after implantation in coronary arteries.

These features of the Freesolve RMS may be of value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil while leaving the vessel implant-free, stated Biotronik.

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March 18, 2024

Biotronik’s Freesolve BTK RMS for CLTI Granted FDA Breakthrough Device Designation

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