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 implantation2, consistent performance, regardless of lesion characteristics, and restoration of vasomotion.3"Having closely observed the evolution of resorbable magnesium scaffolds, the Freesolve RMS achieves a 99.3% resorption rate at 12 months and provides better scaffolding than its predecessors," said Prof. Michael Haude, Rheinland Klinikum, Neuss, Germany. "The enhanced properties of the Freesolve RMS can establish a true alternative to DES, benefitting from the advantages of a resorbable device while maintaining a reliable and predictable outcome with the long-term sa
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BIOTRONIK announced today the opening of its new Asia Pacific Manufacturing and Research Hub. The 20,000 m² site will serve as the company’s central hub in Asia-Pacific, with hundreds of employees working in manufacturing, quality, research & development (R&D), and sales and marketing. BIOTRONIK, founded in Berlin, Germany, in 1963 is a pioneer in implantable pacemakers, defibrillators, and vascular intervention for 60 years. BIOTRONIK’s presence in Singapore began in 2012, and in 2016, the company inaugurated its first manufacturing site, complementing its high-quality manufacturing sites in Germany, Switzerland and the United States. Now in 2023, the new facility has been designed with an emphasis on workspace agility for modern, optimized collaboration. The new site includes several spacious cleanrooms and laboratories developing and manufacturing state-of-the art Cardiac Rhythm Management (CRM) devices. “We are excited to be the first major manufacturer in the cardiac rhythm mana
BIOTRONIK announced today the enrollment of the first patient in the BIOMAG-II trial aiming to evaluate the safety and clinical performance of its new-generation resorbable magnesium scaffold (RMS), Freesolve™, compared to a contemporary drug-eluting stent (DES). "We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG - University Hospital Geneva in Switzerland. "Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise." The BIOMAG-II trial is a prospective, international multi-center randomized-controlled study spanning 21 countries across Europe and the Asia-Pacific region
Los resultados del estudio MATRIX muestran que la alta precisión en la detección de los sistemas DAI DX con un solo cable para los episodios de FA (99,7 % para episodios ≥1 h), combinada con el potente rendimiento de transmisión de BIOTRONIK Home Monitoring®, permite la monitorización remota fiable de la FA subclínica recomendada por las guías. Los resultados se publicaron en Europace a principios de esta semana. 1MATRIX evaluó la utilidad del sistema DAI DX (detección de la señal auricular mediante un dípolo flotante integrado en el cable del DAI) para la monitorización remota de los episodios de alta frecuencia auricular (AHRE) y la evolución de su duración. Además, el estudio analizó las implicaciones clínicas de la detección y la evolución de los AHRE. El resultado del estudio debe interpretarse en el contexto de las directrices sobre la FA de 2020 de la Sociedad Europea de Cardiología, que recomiendan la monitorización remota de los AHRE detectados con disp
Material compliance is concerned with environmental and international laws and regulations that restrict or even prohibit the use of various substances in products. The monitoring of substances of very high concern (SVHC candidates) is regulated by the REACH regulation. We are closely watching the development of the candidate list established according to article 59. If a product contains SVHC candidates of at least 0.1% downstream users must be notified (Article 33 (1)). The following product information sheets depict our current state of knowledge. If there is no product information sheet available, the product does not contain SVHC candidates to the best of our knowledge.
Cardiac catheterization labs can be complicated workplaces when it comes to occupational safety.
This year is a special year for BIOTRONIK, one in which we mark sixty years of service in the healthcare community.
