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

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

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

New two-year follow-up data from the BIOMAG-I first-in-human trial confirms a reliable and predictable long-term safety profile for Freesolve™, the third-generation resorbable magnesium scaffold (RMS), establishing it as a true alternative to contemporary drug-eluting stents (DES). The results were presented by Prof. Dr. Michael Haude at the EuroPCR 2024 conference yesterday in Paris. At the 24-month follow-up, the incidence of target lesion failure (TLF) was 3.5% alongside a corresponding 3.5% incidence of target lesion revascularization (TLR) compares favorably with various second-generation

BIOTRONIK announced today the enrollment of the first patient in the BIOMAG-II trial aiming to evaluate the safety and clinical performance of its new-generation resorbable magnesium scaffold (RMS), Freesolve™, compared to a contemporary drug-eluting stent (DES). "We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG

As the COVID-19 pandemic continues, we are conscious of the enormous strain that you are all under. We share your concerns about the spread of the virus and the disruption it is causing globally. We are doing what we can to help minimize this disruption and to provide support so that you can focus on the critical task of saving lives. To this end, we would like to inform you of the following:

The US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communication technology. If exploited, these vulnerabilities can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions. The FDA has said it is not aware of any confirmed adverse events related to these vulnerabilities although software to exploit

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

The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance

CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to