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)
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.”
-END-
For more information, please visit: Freesolve RMS
FreesolveTM: CAUTION - Investigational Device. Limited by United States Law to Investigational Use.
FreesolveTM BTK RMS is not commercially available
FreesolveTM 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 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.
Related Press Releases
-
Image
BÜLACH, SwitzerlandPress ReleaseCE-approval for BIOTRONIK’s Next-Gen Metallic Bioresorbable Scaffold Freesolve
BIOTRONIK announces the CE approval and launch of Freesolve™ Resorbable Magnesium Scaffold (RMS). This third generation RMS has been engineered to provide optimized vessel support, yet achieves magnesium resorption within 12 months. 1 The new Freesolve RMS is a groundbreaking vascular advancement based on reliable clinical evidence. Recent BIOMAG-I trial data highlights an exceptional 99.3% magnesium strut degradation 12 months after implantation 2 , consistent performance, regardless of lesion characteristics, and restoration of vasomotion. 3 "Having closely observed the evolution of
-
Image
BÜLACH, SwitzerlandPress ReleaseBIOTRONIK and IMDS Join Forces to Launch Innovative Micro Rx Catheter
BIOTRONIK is proud to introduce the Micro Rx™ catheter, a novel rapid exchange microcatheter developed to easily enhance guidewire support during percutaneous coronary interventions (PCI). This cutting-edge device, exclusively distributed by BIOTRONIK, is manufactured by IMDS (Interventional Medical Device Solutions). Micro Rx catheter marks the fourth IMDS product BIOTRONIK has brought to the U.S., creating a compelling portfolio of devices which includes NHancer Rx , TrapIT , and ReCross catheters. The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers
-
Image
BÜLACH, SwitzerlandPress ReleaseTwo-Year BIOPACT Randomized Controlled Trial (RCT) Analysis Demonstrates “Persistent Excellence” for Low-Profile Passeo-18 Lux DCB
BIOTRONIK announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress. The randomized controlled non-inferiority trial evaluated the safety and efficacy of the Passeo®-18 Lux® drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic), and showed excellent results for both balloons through 24 months. 1 The prospective, multicenter, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with
-
Image
AMSTERDAM, The NetherlandsPress ReleaseBIOMAG-I Study OCT Analysis Confirmed That BIOTRONIK’s Newest Resorbable Magnesium Scaffold Resorbed at 12 Months
New data from the BIOMAG-I first-in-human trial shed light on the vascular healing process following the implantation of DREAMS 3G, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS). A detailed intravascular optical coherence tomography (OCT) analysis demonstrated that 99.3% of the struts completely degraded at one year. 1 Dr. Masaru Seguchi from the German Heart Centre in Munich, Germany presented the findings at the European Society of Cardiology’s (ESC) congress in Amsterdam. While earlier BIOMAG-I study results provided favorable outcomes with regards to late lumen loss at