Press Releases and Statements

BIOTRONIK today announced the completion of six-month clinical outcomes from the RESET-AF 3D study evaluating the investigational ElePulse ® Pulsed Field Ablation (PFA) System in patients with symptomatic paroxysmal atrial fibrillation (AF). The results demonstrated strong efficacy and an excellent safety profile. RESET-AF 3D is a prospective, multicenter study required for CE marking. It has been designed to evaluate the performance and safety of the ElePulse PFA System. Among more than 100 evaluable patients, more than 90% remained free from recurring AF at six months following treatment

BIOTRONIK is aware of the recently disclosed critical PHP vulnerabilities (CVE-2026-109618 and CVE-2026-109619) that have received significant attention across the cybersecurity community. BIOTRONIK conducted a thorough review of its systems. Based on our Software Bill of Materials (SBOM), we confirmed that no PHP components are used in our medical device systems. All exposure to the vulnerability in adjacent and supporting services has been remediated. Immediate action was taken to upgrade or temporarily shut down affected services for maintenance. We continue to monitor our systems closely. 

BIOTRONIK, a global leader in cardiovascular medical technology, today announced the first U.S. implant of its Acticor Sky DX cardiac resynchronization therapy defibrillator (CRT-D) system. This marks an important milestone following recent U.S. Food and Drug Administration (FDA) approval of its broader Acticor Sky and Rivacor Sky device family. The procedure was successfully performed by Niraj Varma, MD, PhD, Electrophysiologist at Cleveland Clinic, and represents the first clinical use of Acticor Sky CRT-DX in the United States. “In performing the first U.S. implant of this device, what

BIOTRONIK, 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

BIOTRONIK-Supported CMR-GUIDE Trial Evaluates Scar-Based Risk Stratification for ICD Therapy Primary Endpoint Neutral; Secondary Endpoint Shows Reduced Sudden Cardiac Death with ICD Therapy Results from the CMR-GUIDE study were presented by Principal Investigator Prof Dr. Joseph Selvanayagam, Chair of Cardiovascular Medicine at Flinders University, Flinders Medical Centre, Adelaide, Australia, during a Hotline Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. The findings were also published online in JAMA. Current guidelines generally do not recommend

BIOTRONIK Neuro today announced the launch of Embrace One ® Proactive Intelligence, a proprietary AI capability that advances proactive care for patients implanted with the Prospera ® Spinal Cord Stimulation (SCS) System. BIOTRONIK Neuro collects more than 200 data points per patient daily through automatic, objective remote monitoring, and the new AI capability analyzes this data to identify early signals that may indicate a patient could benefit from additional support or therapy optimization. The AI model does not make clinical decisions or adjust therapy. Instead, it provides additional

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

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

Late-breaking results from the sex‑balanced, BIOTRONIK-funded study presented at EHRA 2026 Data shows associations between contemporary guideline-directed therapies and improved outcomes in patients with non‑ischemic cardiomyopathy PARIS, France – In a late-breaking trial session at the European Heart Rhythm Association (EHRA) 2026 Congress, principal investigator Valentina Kutyifa, MD, PhD, presented new data from the prospective, sex‑balanced BIO‑LIBRA study. The analysis shows that modern guideline-directed medical therapy (GDMT)—specifically angiotensin receptor–neprilysin inhibitors (ARNI

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