Press Releases and Statements

BIOTRONIK, a global leader in medical technology, today announced the first European implantations of its LivIQ leadless pacemaker system as part of the BIO-LivIQ study. The study’s objective is to evaluate the safety and efficacy of LivIQ, including its ability to deliver atrioventricular (AV) synchronous pacing. By enabling AV synchrony at rest and during exercise, LivIQ aims to better address real‑world patient needs, potentially benefiting a broader group of patients, including younger and more active individuals. The procedures were performed by Prof. Christophe Garweg, BIO-LivIQ Steering

BIOTRONIK, die Charité – Universitätsmedizin Berlin, and the German Heart Center Foundation today announced a research and innovation partnership focused on advancing digital and translational cardiology. The collaboration will bring together world-class clinical cardiovascular expertise at Deutsches Herzzentrum der Charité (DHZC) with BIOTRONIK’s strength in active cardiac devices, artificial intelligence, and connected health technologies. The partnership builds on existing projects in cardiovascular healthcare, including publicly funded initiatives. The cooperation framework will span from

Results from the multicenter CRT‑NEXT Study show that CRT‑DX, BIOTRONIK’s 2-lead CRT-D system, is as safe and effective as conventional 3-lead CRT‑D therapy. The study confirms that most CRT candidates do not develop the need for atrial pacing in the long term and can benefit from therapy with fewer leads. Coordinating Investigator Dr. Mauro Biffi presented the novel data at the American College of Cardiology (ACC) Annual Scientific Session in New Orleans. The results have also been published online in Circulation. CRT‑NEXT is a prospective, multicenter, randomized, controlled, interventional

International BIO-LivIQ Study Will Generate Evidence for Global LivIQ Leadless Pacemaker Approvals Far-Field Sensing and AV-Synchronous Pacing Performance Will be Validated by Real World Clinical Data BIOTRONIK today announced the initiation of its global pivotal study evaluating the LivIQ leadless pacemaker system. This next-generation single‑device solution is designed to deliver atrioventricular (AV)-synchrony using advanced electrical far‑field sensing. First implantations within this study have been completed at the Kokura Memorial Hospital in Kitakyushu, Japan and the National Cerebral

BIOTRONIK today announced the launch of the new Acticor Sky and Rivacor Sky device family featuring the world’s first CE-approved left bundle branch area pacing (LBBAP) high-voltage device. These next-generation implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT‑Ds) are now available across CE markets. The first European commercial implant was performed at University Hospital Frankfurt by Dr. Anastasia Falagkari and Prof. Dr. Reza Wakili. The team implanted the CRT-D device Rivacor Sky HF-T in an 87‑year‑old patient with ischemic

Extending BIOTRONIK’s DX Technology to leadless pacing World’s first leadless pacemaker to deliver AV synchronous pacing using atrial electrical far-field signals BIOTRONIK, a global leader in cardiovascular medical technology, today announced the successful first-in-human implantations of its LivIQ leadless pacemaker system. This was part of the BIO|CONCEPT.LivIQ study, a pre‑market clinical investigation designed to evaluate the system’s preliminary safety and performance. The initial procedures were performed in Australia by Dr. Paul Gould at Princess Alexandra Hospital in Brisbane as well

At the Digital Heart Summit 2025 in Berlin, 120 leading experts gathered to explore how digital innovation is reshaping cardiovascular care. Organized by BIOTRONIK, the event spotlighted the growing impact of artificial intelligence, real-world data, and patient-centric technologies in redefining diagnostics and treatment strategies. Discussions highlighted how digital tools are moving toward proactive, preventive care. For the experts, the vision is clear: by integrating AI-driven insights with patient engagement strategies, connected platforms can support informed decision-making across

The Multicenter Study Will Evaluate the ElePulse™ PFA System in Patients with Symptomatic, Drug-Refractory Paroxysmal Atrial Fibrillation ElePulse Introduces a True Single-Shot, Single-Position Approach BIOTRONIK today announced the enrollment of the first patient in the RESET  AF 3D Study, a clinical study to evaluate the ElePulse™ Pulsed Field Ablation (PFA) System for performance in patients in the treatment of atrial fibrillation (AF). The study aims to support CE Mark approval for the ElePulse PFA System, which introduces a single-shot, single-position approach to pulmonary vein isolation

This Three-Year Collaboration Aims to Deliver Scalable Health Solutions for Improved Disease Management The Initiative Hopes to Benefit Patients Particularly in Remote or Underserved Regions with Limited Access to Care SYDNEY, Australia – BIOTRONIK, a global leader in medical technology, and the University of Sydney, one of the world’s top research and teaching institutions, have signed a Memorandum of Understanding (MoU) to jointly advance digital and connected health innovations through 2028. By combining BIOTRONIK’s expertise in implanted cardiac devices and remote monitoring with the

BIOTRONIK, a global leader in medical technology, today announced the market release of Solia CSP S, the latest innovation in its growing portfolio of Conduction System Pacing (CSP) solutions. Solia CSP S is the first and only pacing lead worldwide that combines a fixed screw design with a stylet-driven implantation approach 1, offering physicians a new solution designed to simplify CSP procedures while enhancing control and precision. The first global commercial implants were successfully performed by Dr. Óscar Cano at the University and Polytechnic La Fe Hospital of Valencia, Spain. “In my

BIOTRONIK, a global leader in medical technology, and a pioneer in cardiovascular, endovascular, and neuromodulation solutions, today announced a strategic shift to strengthen its leadership in active implantable devices and digital healthcare. Leveraging future technologies, including artificial intelligence (AI), remote patient monitoring and connected healthcare platforms, BIOTRONIK is at the forefront of improving patient outcomes and optimizing clinical workflows. These innovations are designed to enhance the efficiency and accessibility of care, enabling healthcare providers with next

The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s