Press Releases and Statements

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

BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, today announces the launch of BIOMAG-LL, a pre-market trial focused on confirming the safety and clinical performance of Freesolve ® Resorbable Magnesium Scaffold (RMS), for the treatment of long de novo lesions in native coronary arteries. The BIOMAG-LL is a prospective, international, multi-center, single arm pre-market study that will enroll 100 patients in Europe with de novo coronary artery stenosis and long lesions. Given that the Freesolve RMS is already CE-certified for shorter lesions, the

BIOTRONIK Neuro will unveil new data from the BENEFIT-03 clinical study at the North American Neuromodulation Society (NANS) 2025 Annual Meeting. The findings highlight the transformative potential of its Prospera TM Spinal Cord Stimulation (SCS) system. This system integrates RESONANCE™ multiphase stimulation with automatic, objective, daily remote monitoring and proactive care* to optimize management of SCS patients’ chronic pain. 1 The 24-month data revealed that participants experienced significant pain relief, along with better sleep, improved function and reduced opioid medication use

BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, is pleased to announce today the approval of two new indications for the Orsiro ® Mission Drug-Eluting Stent (DES): One-month Dual Antiplatelet Therapy (DAPT) for High Bleeding Risk (HBR) Patients: Allows practitioners to offer personalized, shorter DAPT durations to their patients at high risk of bleeding events, in accordance with the most recent guidelines. Calcified Lesions Treatment: Allows practitioners to target more complex lesions with moderate or severe calcification. These new indications

BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, is pleased to announce the first in-human implantations in BIO|Master.CSP study examining the use of the investigational BIOTRONIK next-generation Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). Left bundle branch area pacing is an emerging technique providing a more physiologic activation of cardiac tissue in patients needing ventricular pacing support. This pacing site may also help avoid the detrimental effects of traditional right ventricular pacing. 1, 2 Building on the