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 […]

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.”

Freesolve RMS has BIOmag magnesium alloy and proven Orsiro drug-eluting stent (DES) coating technology to give safety, improved deliverability and optimal performance and vessel support during and after implantation. According to Biotronik, it has shown 99.6% degradation of magnesium was observed 12 months after implantation in coronary arteries. These characteristics are beneficial in BTK interventions, where vessel scaffolding is desired in the short term to resist vessel recoil.

“Biotronik’s focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation,” President of Vascular Intervention Jörg Pochert said. “Our efforts to expand therapeutic possibilities, underlined by the introduction of the Freesolve RMS for coronary artery disease treatment, will continue in the BTK indication with this groundbreaking innovation.”

Currently, Freesolve RMS is only available in CE mark-accepting countries and is limited to investigational use in the U.S.

Original Article: (https://www.massdevice.com/biotronik-wins-breakthrough-nod-for-freesolve-btk-resorbable-magnesium-scaffold/)