Sam Brusco, Associate Editor03.18.24
Biotronik has earned U.S. Food and Drug Administration (FDA) breakthrough status for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS).
The Freesolve BTK RMS is designed for patients with chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs.
The newly EU-launched Freesolve RMS for coronary artery lesions, based on the BIOmag magnesium alloy and Orsiro drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation. It’s demonstrated 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries, according to Biotronik.
The company believes these characteristics of the Freesolve RMS may be of value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free.
“BIOTRONIK's focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation,” said Dr. Jörg Pochert, president of Vascular Intervention at Biotronik. “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.”
“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," added 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.”
Last month, the company introduced the Micro Rx catheter, a rapid exchange microcatheter to enhance guidewire support during percutaneous coronary interventions (PCI).
The Freesolve BTK RMS is designed for patients with chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs.
The newly EU-launched Freesolve RMS for coronary artery lesions, based on the BIOmag magnesium alloy and Orsiro drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation. It’s demonstrated 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries, according to Biotronik.
The company believes these characteristics of the Freesolve RMS may be of value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free.
“BIOTRONIK's focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation,” said Dr. Jörg Pochert, president of Vascular Intervention at Biotronik. “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.”
“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," added 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.”
Last month, the company introduced the Micro Rx catheter, a rapid exchange microcatheter to enhance guidewire support during percutaneous coronary interventions (PCI).