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Biotronik wins breakthrough nod for Freesolve BTK resorbable magnesium scaffold

Biotronik this week announced it received FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS).

The Berlin, Germany-based cardiac rhythm company designed Freesolve for individuals suffering from chronic limb-threatening ischemia (CLTI). The newly launched device is not coronary artery lesions.

“This breakthrough device designation for the Freesolve RMS for BTK treatment is a significant milestone in advancing treatment options. Biotronik is committed to design our products to enhance the lives of patients,” Biotronik’s U.S. President Ryan Walters said in a news release “Our next-generation RMS represents a leap forward over existing resorbable technology, incorporating technical innovations intended to address physicians’ needs and optimize outcomes for patients suffering from CLTI.”

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