FDA Breakthrough Device Designation for BIOTRONIK Freesolve™ Below-the-Knee Resorbable Magnesium Scaffold (RMS)

The Freesolve BTK RMS is designed for patients suffering from chronic limb-threatening ischemia (CLTI)

BUELACH, Switzerland, March 21, 2024 /PRNewswire/ -- BIOTRONIK has been granted Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve^™ below-the-knee resorbable magnesium scaffold (BTK RMS).

The Freesolve BTK RMS is designed for individuals suffering from 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.¹

To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval.

The newly CE launched Freesolve RMS for coronary artery lesions, based on the BIOmag^® magnesium alloy and the proven Orsiro^® drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation.^2,3 It has shown 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries.⁴  

These characteristics of the Freesolve RMS may be of particular 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," stated Ryan Walters, US 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."

Freesolve^™: CAUTION - Investigational Device. Limited by United States Law to Investigational Use.

Freesolve^™ BTK RMS is not commercially available
Freesolve^™ RMS is available in CE-mark accepting countries

Freesolve, BIOmag and Orsiro are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

About BIOTRONIK:
At BIOTRONIK, patient well-being is our top priority and has been for more than 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.

References:
¹ Kwong M., et al. Updated estimates for the burden of chronic limb-threatening ischemia in the Medicare population, Journal of Vascular Surgery, Volume 77, Issue 6, 2023, 1760-1775

² Seguchi M., et al. Preclinical evaluation of the degradation kinetics of third generation resorbable magnesium scaffolds. Eurointervention; 2023;18-online publish-ahead-of-print January 2023. DOI: 10.4244/EIJ-D-22-00718

³ BIOTRONIK data on file.

⁴ Seguchi M., et al. Twelve-months vessel healing profile following the novel resorbable magnesium scaffold implantation: an intravascular OCT analysis of the BIOMAG-I trial. European Heart Journal; Volume 44, Issue Supplement_2, November 2023, ehad655.2180, https://doi.org/10.1093/eurheartj/ehad655.2180 

SOURCE BIOTRONIK