Innovation

BIOTRONIK’s Freesolve BTK RMS Granted FDA Breakthrough Device Designation

In a significant development for patients combatting chronic limb-threatening ischemia (CLTI), the Freesolve™ below-the-knee resorbable magnesium scaffold (BTK RMS) by BIOTRONIK has received the Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA). This designation, heralded from Buelach, Switzerland on March 21, 2024, showcases BIOTRONIK's continued stride in mitigating the life-altering impacts of vascular diseases.

The Freesolve BTK RMS, specifically crafted for those affected by CLTI, demonstrates BIOTRONIK's unwavering commitment to revolutionizing patient care. This condition represents the most critical stage of peripheral arterial disease (PAD), affecting an estimated 11% of the 200 million individuals worldwide who suffer from PAD. CLTI is notorious for its ties to excessively high rates of amputations and mortality, alongside the substantial costs it imposes on healthcare systems.

Understanding Breakthrough Device Designation

The FDA's Breakthrough Device Designation is reserved for innovative medical devices that tackle previously unaddressed medical issues and exhibit the potential to enhance treatment of life-threatening or irreversibly debilitating diseases. Programs like BDD are engineered to expedite the development, evaluation, and review of cutting-edge treatments, ensuring expedient access for patients and healthcare providers. Crucially, this acceleration occurs without compromising the regulatory standards required for pre-market approval.

The Innovation Behind Freesolve BTK RMS

The genesis of the Freesolve BTK RMS lies in the newly CE launched Freesolve RMS for treating coronary artery lesions, built upon the BIOTRONIK's proprietary BIOmag® magnesium alloy and the tried-and-true Orsiro® drug-eluting stent (DES) coating technology. What sets this product apart is its amalgamation of safety features, enhanced deliverability, stellar performance, and reliable vessel support both during and post-implantation. Impressively, the magnesium within the RMS has been shown to degrade at a rate of 99.6% within 12 months post-implantation in coronary arteries.

This stellar attribute of the Freesolve RMS is particularly advantageous for below-the-knee interventions where temporary vessel scaffolding is essential to counteract vessel recoil. A pivotal aspect of this innovation is its capacity to fade away, leaving the vessel free of any implants in due course.

Leadership Comments on Breakthrough Designation

Dr. Jörg Pochert, the President of Vascular Intervention at BIOTRONIK, articulates their ethos succinctly by emphasizing the company's stringent focus on vascular interventional excellence, which shines through in strategic investments and a zealous pursuit of innovation. With the introduction of Freesolve RMS to combat coronary artery disease, BIOTRONIK's mission now extends to BTK treatment, powered by this ground-breaking technological feat.

Ryan Walters, the US President at BIOTRONIK, also chimes in, indicating that this breakthrough device designation for the Freesolve RMS marks a significant advancement in the therapy of BTK conditions. Reinforcing the company's ethos, Walters echoes their commitment to designing products that drastically enhance patient outcomes. As BIOTRONIK unveils this next-generation RMS, it embodies an evolutionary leap exceeding the capabilities of pre-existing resorbable technology by assimilating technical ingenuity to satisfy the intricate needs of physicians, consequently optimizing results for patients afflicted with CLTI.

Market and Investigational Status of Freesolve BTK RMS

Currently, Freesolve BTK RMS is categorized as an Investigational Device by the United States Law and is strictly limited to Investigational Use. As of now, the BTK RMS is not commercially available for use in the United States. However, the Freesolve RMS is obtainable in countries that recognize and accept the CE mark, indicating compliance with European Union safety, health, and environmental requirements.

BIOTRONIK: A Pioneer in Medical Technology

Berlin-based BIOTRONIK represents more than six decades of dedication to patient welfare, emerging as a global leader in the medical technology sphere. Their portfolio spans a broad range of products and services that are instrumental in saving lives and enhancing the quality of life for those dealing with heart and blood vessel diseases and chronic pain. True to their resolve, BIOTRONIK is a beacon of innovation, consistently delivering trusted solutions in cardiovascular, endovascular, and neuromodulation technologies. Their global footprint extends to over 100 countries, underpinning their reputation as a driver of medical innovation.

Clinical Impact of Chronic Limb-Threatening Ischemia

In-depth research, such as the study by Kwong M. et al. published in the Journal of Vascular Surgery, highlights the significant burden posed by chronic limb-threatening ischemia on the Medicare population. CLTI, not only compromises the quality of life of patients but also induces considerable strain on healthcare services due to the complex medical care it necessitates.

The Science Behind the Freesolve RMS Success

Research published ahead-of-print in January 2023 by Seguchi M., et al. in Eurointervention delves into the degradation kinetics of the third-generation resorbable magnesium scaffolds, laying the groundwork for the success of the Freesolve RMS. Further studies endorsed by BIOTRONIK's data on file corroborate these outcomes.

Additionally, the BIOMAG-I trial, detailed in the European Heart Journal, offers insight into the twelve-month vascular healing profile post-implementation of this novel resorbable magnesium scaffold, affirming the exemplary healing afforded by this technology. For more comprehensive insights, Seguchi M., et al.'s study can be accessed at European Heart Journal.

Insights From the President of Vascular Intervention

Dr. Jörg Pochert's commitment to innovation in the realm of vascular intervention is unyielding. The Freesolve RMS, representing a new horizon for the treatment of coronary artery disease, is poised to make similar inroads in the BTK segment thanks to BIOTRONIK’s innovative interventions.

U.S. President’s Vision for Patient-Centric Design

Upholding the patients-at-the-forefront philosophy, Ryan Walters, the US President of BIOTRONIK, reinforces the organization's resolve to pioneer product designs that dramatically elevate patient care standards, as showcased by the next-gen Freesolve RMS.

Conclusion and Forward Outlook

The FDA's endorsement of the Freesolve BTK RMS as a breakthrough device underscores BIOTRONIK's trailblazing role in advancing treatment modalities for those grappling with severe vascular diseases. As the medical community eagerly awaits the commercial availability and deployment of the Freesolve BTK RMS in the US, its investigational use stands as a beacon of hope and innovation. Through diligent research, unwavering dedication to improving patient outcomes, and a global vision for a healthier future, BIOTRONIK continues to define excellence in medical technology.

About BIOTRONIK

Empathy for patient well-being and an unrelenting pursuit of technological harmony with the human body encapsulate the ethos of BIOTRONIK. As a preeminent entity in global medical technology, their commitment to honing cardiovascular, endovascular, and neuromodulation solutions is unfaltering—evident in their array of life-saving products and services. Headquartered in the heart of Berlin, Germany, BIOTRONIK's innovations circulate worldwide, touching lives across the globe in over a hundred countries.

Empirical Evidence and Reference Points

The conclusions and findings presented in this article are buttressed by prolific research, notably by Kwong M. et al. on the pressing challenge of chronic limb-threatening ischemia and its influence on the Medicare population; Seguchi M., et al.'s ahead-of-print publication on the degradation phenomena involved in third-gen magnesium scaffolds; and further scholarly efforts delineating the post-implant healing dynamics as captured in the BIOMAG-I trial featured in the European Heart Journal. It's through these empirical milestones that BIOTRONIK's Freesolve RMS has carved its niche, standing testament to the marriage of theoretical research and practical innovation.

Navigating the Future of Vascular Interventions with BIOTRONIK

In a landscape marred by the complexities of vascular conditions, BIOTRONIK's Freesolve BTK RMS arrives as a harbinger of hope—heralded by the FDA's Breakthrough Device Designation. As the medical fraternity and the patient community anticipate the strides this breakthrough will enable, the echelons of BIOTRONIK — from Dr. Jörg Pochert to Ryan Walters — reflect a united front dedicated to overcoming the challenges set forth by diseases like CLTI. With the fusion of innovation and meticulous design, the true potential of vascular interventions is merely on the horizon, promising a transformative impact on cardiovascular care.

The narrative of BIOTRONIK's Freesolve BTK RMS is far from conclusion—it's an ongoing saga of medical innovation, determination, and the relentless pursuit of excellence. For patients, physicians, and stakeholders alike, the future sparkles with the promise of discoveries yet to unfold, buoyed by the pivotal endorsement of regulatory icons like the FDA. It is a future where ground-breaking technologies such as the Freesolve BTK RMS not only challenge the status quo but redefine it entirely, all in the service of humanity's quest for health and wellness.

In capturing the essence of BIOTRONIK's pioneering spirit, it becomes clear that the vision to perfectly align technology with the human body isn't purely aspirational—it's both the journey and the destination. As BIOTRONIK cements its place as a beacon in the medical technosphere, the Freesolve BTK RMS stands as a testament to innovation, a legacy etched in the annals of vascular intervention history, and a steadfast commitment to the heartbeats of humanity.