Press Releases and Statements

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

Building on a generous contribution from BIOTRONIK, the German Heart Center Foundation is establishing an endowed professorship in Digital and Translational Cardiology at Charité – Universitätsmedizin Berlin with a focus on electrophysiology and heart failure. This initiative aims to attract and retain exceptional talent in Berlin, further strengthening innovative academic research in digital and translational cardiology. Embedded within Deutsches Herzzentrum der Charité, the professorship will operate with full academic independence while benefiting from a strong collaborative framework

BIOTRONIK’s BIOWOMEN Study Enrolled 474 Patients Across Eight Countries in Europe and Israel Addressing Critical Gaps as Women Often Remain Undiagnosed and Undertreated in Heart Failure This International Women’s Day, BIOTRONIK highlights a critical advance in women’s heart health with the BIOWOMEN trial, an international study evaluating sex-specific responses to cardiac resynchronization therapy (CRT) in heart failure patients. Published in the International Journal of Cardiology, the results confirm that women experience significantly greater clinical and echocardiographic benefits from CRT

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

BIOTRONIK, a global leader in medical technology, is marking a significant achievement at its Asia-Pacific Hub (BIOHUB) in Singapore with the production of three million cardiac rhythm management (CRM) leads. Since beginning operations in late 2017, BIOTRONIK has experienced significant growth in Singapore. Each lead manufactured in Singapore represents a critical component in cardiac rhythm therapy systems including devices such as pacemakers and implantable cardioverter defibrillators (ICDs). These leads support patients who require precise, reliable electrical signaling to maintain healthy

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 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 University of Sydney’s

BIOTRONIK today announced the successful first-in-human implantation of a device from its new Acticor/Rivacor Sky ICD/CRT-D devices, specifically engineered to support conduction system pacing via left bundle branch area pacing (LBBAP). This emerging technique provides a more physiological activation of cardiac tissue for patients requiring ventricular pacing. The first system has been implanted at the Gold Coast University Hospital in Queensland, Australia by Cardiac Electrophyisologist Dr. Robert Park. This implantation took place as part of the First-in-Human (FIH) study, involving

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