Press Releases and Statements

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

BIOTRONIK, a global leader in medical technology, today announced a strategic distribution agreement with CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac arrhythmias. BIOTRONIK will serve as the exclusive distributor of the Centauri™ Pulsed Field Ablation (PFA) System in selected European countries. This collaboration represents a significant milestone in the commercial expansion of Centauri — a next generation focal PFA system that provides physicians with highly controllable and versatile solution for cardiac ablation in the treatment of

For the third year in a row, BIOTRONIK has been named “Supplier of the Year” in the category Medical by Prospitalia. This hattrick sets a new benchmark and distinction that no other company has ever achieved in the Medtech field. As a company, we are honored by the trust and recognition from our clinical partners. The Prospitalia Supplier Award emphasizes BIOTRONIK’s unwavering commitment to quality, reliability, and customer-centric service in a highly competitive market. The award, presented during the Prospitalia Congress 2025 in Frankfurt, recognizes outstanding performance across key

Today BIOTRONIK announces the enrollment of the first patient in the Leave Nothing Behind-Trial. The first implantation was performed by Dr. Mohamed Ayoub at the Heart and Diabetes Center North Rhine-Westphalia, Germany. The trial aims to demonstrate the non-inferiority of drug-coated balloons (DCB) or DCBs in combination with Resorbable Magnesium Scaffolds (RMS) compared to drug-eluting stents (DES) in chronic total occlusions (CTO) in percutaneous coronary interventions (PCI). The prospective, single-center, single-blind, randomized trial evaluates the efficacy of the Pantera ® Lux ® DCB and

New results from the BIOMAG-I first-in-human trial demonstrated an excellent safety and efficacy profile for Freesolve ®, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS) at three years follow-up. Prof. Dr. Michael Haude presented these new data at the EuroPCR 2025 conference in Paris. At the 36-month follow-up, the target lesion failure (TLF) rate remained at 3.5%, consisting of four cases of clinically driven target lesion revascularization (CD-TLR), of which only one event occurred beyond the resorption period of the scaffold. No cases of target-vessel myocardial infarction

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