The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.
Lake Oswego, Oregon-based Biotronik based its system on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Previous data demonstrated 99.6% degradation of magnesium 12 months after implantation into coronary arteries.
In BTK interventions, Biotronik says the Freesolve’s characteristics can offer particular value. In these situations, vessel scaffolding in the short-term resists vessel recoil, but Freesolve ultimately leaves the vessel implant-free.
“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,” said Ryan Walters, U.S. president at Biotronik. “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.”