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 study that enrolled 636 patients across 23 Italian centers. It is the largest evaluation to date of CRT-DX therapy—a cardiac resynchronization defibrillator system that preserves full atrial sensing capabilities without requiring an atrial lead. The study demonstrated: 

• Three times fewer atrial‑lead–related complications compared to conventional 3-lead systems 
• 14% shorter implantation procedures, potentially improving workflow efficiency and reducing patient burden 
• Comparable CRT response rates and functional capacity outcomes 
• Extremely rare long‑term need for atrial pacing in appropriately selected CRT‑DX patients 

“These results confirm what early pilot studies suggested: that for the vast majority of CRT candidates, atrial pacing is not needed in the long term,” said Dr. Mauro Biffi, Clinical Cardiologist and Director of Electrophysiology at Sant'Orsola-Malpighi Polyclinic, Bologna, Italy. “By removing the atrial lead, CRT‑DX offers meaningful advantages in safety and procedure simplification—without compromising clinical performance.” 

The study reinforces the clinical relevance of CRT‑DX technology by showing that patient selection is based on simple criteria. This makes it easier for physicians, including those new to the system, to adopt the approach. With strong evidence supporting its non‑inferiority to conventional CRT-D systems, along with better safety due to fewer atrial-lead related issues, CRT-DX offers a compelling new way using reduced hardware while preserving therapeutic effectiveness. 

“BIOTRONIK’s CRT-DX system is the only 2-lead CRT‑D solution on the market,” said Dr. David Hayes, Chief Medical Officer at BIOTRONIK. “The CRT‑NEXT results clearly demonstrate the system’s distinct advantages for both clinicians and patients. This data reinforces our leadership in CRT innovation and offers strong clinical support for a significant evolution in CRT treatment.” 

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About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.    

About BIOTRONIK DX Technology 

BIOTRONIK’s DX technology delivers complete atrial and ventricular diagnostics while using fewer leads than conventional systems—one instead of two in single‑chamber ICDs and two instead of three in CRT‑D devices. Using a specialized right‑ventricular lead with atrial sensing capability, DX systems provide high‑resolution intracardiac electrograms that support precise arrhythmia discrimination, enhanced diagnostic accuracy, and improved treatment efficiency. When combined with BIOTRONIK Home Monitoring^®, DX technology enables earlier detection of atrial arrhythmias, while reduced hardware simplifies implantation and may lower complication risks, offering dual‑chamber diagnostic benefits with a streamlined system design. 

• 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 and Cardiovascular Center (NCVC) in Osaka, Japan. “The BIOTRONIK leadless pacemaker system was remarkably straightforward to implant. Catheter navigation and deployment were intuitive, helping us to achieve excellent device positioning and initial results,” said Dr. Kenji Ando, Department of Cardiology at Kokura Memorial Hospital.  

“I am pleased to see a highly compelling option emerging for a single device leadless pacemaker, promised to deliver strong AV-synchrony and long-term device performance,” added Dr. Kengo Kusano, Study Principal Investigator at NCVC. 

As a prospective multicenter clinical investigation, the BIO-LivIQ study will enroll 325 patients across 60 sites worldwide. The trial will evaluate device safety, pacing performance, AV-synchrony behavior, and quality-of-life outcomes to generate the evidence required for global regulatory submissions.  

LivIQ continues BIOTRONIK’s long‑standing commitment to physiologic pacing. It uses proven far‑field sensing technology to electrically detect atrial activity and enable a single‑device VDD mode. This advanced sensing approach supports reliable AV synchrony across a broad range of clinical scenarios. Equally important, LivIQ’s highly maneuverable catheter is designed for precise control and predictable placement, creating a smooth, streamlined implantation experience.  

“We are one step closer to providing clinicians with a more intuitive and capable single‑device solution in leadless pacing,” said Dr. Andreas Hecker, Chief Technology Officer at BIOTRONIK. “LivIQ brings together two key advances that address distinct clinical needs. It combines an easy‑to‑handle catheter design that simplifies implantation, and a novel sensing concept that enhances therapy performance across more scenarios.” 

Clinicians seek solutions to avoid complications related to the pacemaker's pocket, infection risks, and an invasive experience. Leadless pacing continues to emerge as an important therapy option and is designed to address these growing needs. 

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CAUTION - Investigational device. Limited to federal (United States) law to investigational use. 

About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.     

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 between BIOTRONIK, the German Heart Center Foundation and Charité. “We are excited to further enhance our longstanding fruitful partnership with BIOTRONIK,” says Prof. Hans Maier, CEO of the German Heart Center Foundation. “This creates a unique environment at the interface of research, clinical excellence and technological innovation.” 

The position is now open for applications via Charité’s official recruitment portal. Interested candidates are invited to submit their applications by 17 April 2026. 

Candidates are expected to contribute expertise across a broad spectrum of fields. These include translational, molecular and clinical research on arrhythmias and heart failure, the development of medical devices, as well as digital health and the application of artificial intelligence in cardiovascular diagnostics and therapy. The successful candidate will join a distinguished group of 14 professors supported by the German Heart Center Foundation. 

“As part of this joint initiative, we are eager to support someone who will help drive cardiovascular innovation through new perspectives and a strong commitment to clinical care. Ensuring that patient needs remain at the center will be key to translating innovation into meaningful improvements in therapy,” says Dr. Volker Lang, Senior Vice President Research & Development at BIOTRONIK.  

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German Heart Center Foundation 

The German Heart Center Foundation is a private, non-profit organization committed to advancing cardiovascular health. In a public–private partnership with Charité, it jointly runs Deutsches Herzzentrum der Charité (DHZC), one of the world’s leading academic heart centers. Through targeted strategic funding initiatives, the foundation supports innovative patient care, translational research and scientific excellence, while fostering outstanding training and education — all for the lasting benefit of patients. 

BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies, Home Monitoring and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.

• 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 than men. With these findings, BIOTRONIK aims to close persistent gaps in cardiovascular diagnosis and treatment.

The BIOWOMEN trial is the largest prospective study of its kind to investigate sex‑specific CRT outcomes. A total of 474 patients (230 women and 244 men) were enrolled across 25 sites in eight countries in Europe and Israel. This level of female participation marks an important step in addressing the historical underrepresentation of women in CRT research. All enrolled patients received BIOTRONIK CRT devices, including Edora HF‑T and Iperia HF‑T systems, or their successors.

Key findings include:

• Greater improvement in left ventricular ejection fraction (LVEF) in women after 12 months (+14.7% vs. +11.5%, p ≤ 0.01)
• Female sex was an independent predictor of CRT response (+2.53% adjusted LVEF improvement, p = 0.023)
• Higher responder rates in women (83.3% vs. 70.6%, p = 0.003), with better reverse remodeling and quality of life
• Lower composite endpoint of death or heart failure hospitalization in women (HR 0.41, p = 0.045)

“Women with heart failure with reduced ejection fraction remain underrepresented in device trials and are less likely to receive cardiac resynchronization therapy in routine practice. The BIOWOMEN study is crucial because it provides the evidence needed to ensure women are recognized, referred, and treated equally when they meet guideline criteria,” said Dr. Lieselot van Erven, Coordinating Clinical Investigator of the BIOWOMEN trial. 

The study results confirm the importance of recognizing sex-specific differences when screening patients for CRT. The findings also align with the updated 2023 Heart Rhythm Society guidelines, which now recognize female sex as a factor associated with better CRT outcomes.

In the International Journal of Cardiology, Dr. Majid Haghjoo, Professor at the Rajaie Cardiovascular Medical and Research Center in Tehran, Iran praised the BIOWOMEN trial as a “clarion call to recognize sex as a critical factor in CRT decision-making.” He emphasized the study’s robust design, balanced enrollment, and clinical relevance, noting that equitable access to CRT for eligible women is not only fair—it is a clinical imperative. These observations appear in the journal’s accompanying editorial.

The BIOWOMEN trial exemplifies BIOTRONIK’s leadership in advancing patient care and demonstrates how scientific research can drive greater equity in treatment. By investing in sex-specific research, BIOTRONIK deepens scientific understanding of how women respond to CRT, empowering physicians to make more informed, personalized treatment decisions.

Find more information about how BIOTRONIK is advocating for female heart health in the current #GoRed Campaign.

About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.   

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 cardiomyopathy requiring an ICD, a history of atrial fibrillation, and an expected high ventricular pacing rate.

“The device’s streamlined programming and diagnostics were immediately noticeable,” said Dr. Falagkari, Senior Attending Physician for Electrophysiology. “Pacing in the left bundle branch area provides more physiologic and synchronized heart contractions, which is exactly what we aim for in resynchronization therapy. The CRT-DX technology allows a dual-lead CRT approach, contributing to a more efficient implantation procedure. In addition, based on the two-lead-only approach it is very likely to reduce also complication risk in the future.”

The new device family introduces advanced therapies that elevate patients’ quality of life. Key features of the new devices include:

• Physiological Pacing Options: Dedicated programming and streamlined workflows for LBBAP make implementation fast and intuitive. Closed Loop Stimulation (CLS) offers a uniquely physiologic pacing option, continuously responding to real cardiac demand beyond conventional rate response systems.
• Enhanced Arrhythmia Management: Smart atrial fibrillation detection and discrimination via BIOTRONIK’s unique DX technology enables early intervention.
• Optimized Therapy Delivery: BIOTRONIK’s unique anti-tachycardia pacing (ATP) suite combines atrial and ventricular ATP to reduce atrial arrhythmias as well as shock burden, improving patients’ quality of life.
• Workflow Efficiency: MRI Guard 24/7 delivers full-body MRI access automatically, eliminating pre- and post-scan programming to reduce touchpoints needed with the patient. 

“With Acticor and Rivacor Sky, we created a platform that elevates cardiac care,” said Dr. Andreas Hecker, Chief Technology Officer at BIOTRONIK. “This new device family combines proven reliability with advanced algorithms to tailor therapy more precisely while simplifying workflows that support physicians in their daily work.”

Prof. Wakili, Deputy Director of Cardiology at University Hospital Frankfurt, adds his first experience with the new devices: “Combining physiological pacing capabilities with enhanced DX atrial sensing in a single platform gives us practical advantages in daily clinical decision‑making. It allows us to identify arrhythmias earlier and tailor therapy pathways more accurately, which is essential when managing patients with complex rhythm disorders.”

With conduction system pacing (CSP) gaining recognition as a more physiological pacing strategy, healthcare teams are increasingly relying on systems that support LBBAP workflows without adding procedural complexity. Acticor Sky and Rivacor Sky represent a significant advancement in this field as the world’s first fully approved LBBAP-capable high-voltage devices.

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About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.  

• 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 as Dr. Stewart Healy and Dr. Emily Kotschet at Victorian Heart Hospital in Melbourne. The physicians highlighted the system’s superior handling during implantation. 

“I was extremely impressed with how easy the delivery system was to use,” Dr. Gould summarized his excellent initial experience. “It enables accurate and stable positioning with an added ability to simply reposition if required.” Dr. Healy and Dr. Kotschet emphasized the periprocedural visibility of both the device and delivery system, adding that “BIOTRONIK put a lot of thought into this. The visibility of the tines and the tether are excellent. The delivery system is intuitive, and easy to use.” 

The BIOTRONIK LivIQ leadless pacing system is the world’s first intracardiac pacemaker to use atrial electrical far-field sensing. It enables atrioventricular (AV)-synchronous pacing at rest and during exercise with a single cardiovascular implantable electronic device (CIED). Its design simplifies implantation through intuitive handling and improved procedural visibility. The system is designed to provide reliable rate adaptation—without compromising device longevity. 

“We plan to move into the global pivotal study in the coming months,” said Andreas Hecker, Chief Technology Officer at BIOTRONIK. “Introducing DX technology to leadless pacing represents a major step forward in bradycardia therapy, and we are excited to bring it to patients worldwide soon.” 

Leadless pacing is increasingly adopted to reduce complications associated with traditional transvenous systems, such as lead-related issues and infection risks. BIOTRONIK’s LivIQ system aims to combine these benefits with advanced functionality, setting a new benchmark for leadless pacing technology. 

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CAUTION - Investigational device. Limited to federal (United States) law to investigational use. 

About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.     

Media Contact 

BIOTRONIK Press Office: press@biotronik.com 

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 heart rhythms and carry out their daily activities. This latest milestone underscores both the capacity and the consistent quality of BIOTRONIK’s production processes, as well as the company’s mission to enable better patient outcomes globally. 

“This achievement demonstrates the growing importance of Singapore in improving global access to advanced cardiac care,” said Dr. Andreas Hecker, Chief Technology Officer at BIOTRONIK. “Every lead produced here supports a patient who depends on precise and reliable therapy. I’m very proud of the team here for their expertise, dedication, and deep commitment to delivering the highest-quality medical technology to patients around the world.” 

In December 2023, BIOTRONIK opened its new Asia-Pacific Manufacturing and Research Hub. This 20,000 m² facility integrates manufacturing, quality, and research & development under one roof. The hub employs hundreds of specialists across these areas, featuring modern cleanrooms and laboratories that are dedicated to developing advanced CRM devices. The BIOHUB represents BIOTRONIK’s long‑term commitment to strengthening Singapore’s MedTech ecosystem. 

Catch journalist and marathon runner Marianella Cordero talk about her pacemaker. 

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About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.    

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 approximately 50 patients across 10 centers. The study aims to preliminarily assess the safety and performance of the new devices and to support future clinical trials.  

“It has been our privilege at Gold Coast University Hospital and the Queensland Health Electrophysiology Research Alliance to partner with BIOTRONIK in the trial,” said Dr. Robert Park. “We’re seeing clear benefits for our patients with the enhanced programmability and advanced technology of the new suite of devices. These are complemented by an excellent range of solutions that supports successful conduction system pacing.”  

BIOTRONIK’s next-generation Acticor/Rivacor Sky integrates advanced features to deliver precise, patient-specific therapy. The portfolio includes the world’s first CRT-D device for LBBAP. This enables more natural and synchronized heart contractions using the heart’s intrinsic conduction system. Patients with conditions such as atrioventricular (AV) block or left bundle branch block may particularly benefit from this innovative approach. 

The new Acticor/Rivacor Sky family will be released worldwide upon successful study completion and regulatory approval. 

“We are proud to pioneer advancements in LBBAP,” said Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. “Our enhanced portfolio exemplifies BIOTRONIK’s continued commitment to innovation and excellence in cardiac rhythm management. Setting new standards in cardiac care, we empower physicians to achieve better outcomes and elevate patients’ quality of life.” 

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About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.    

Media Contact

BIOTRONIK Press Office: press@biotronik.com  

• 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 world-class research capabilities and the expertise of the Westmead Applied Research Centre (WARC) in patient-facing digital health tools, the collaboration aims to co-design solutions that address real-world clinical needs. This MoU marks a significant milestone in the evolution of patient-centered, value-based healthcare. 

“This MoU is about more than just technology. It’s about reimagining how we deliver care,” said Jan Ewert, Managing Director, BIOTRONIK Australia and New Zealand. “We aim to create digital tools that integrate into existing workflows and empower clinicians and patients to improve care provision and outcomes.”

As healthcare systems worldwide face increasing pressure from rising costs, an ageing population, workforce shortages, the need for low-cost technology and digital solutions has never been more urgent. Smart, scalable solutions such as remote monitoring and AI-driven decision support can help bridge care gaps, optimize resources, and enable earlier interventions especially for chronic conditions. 

Over the next three years, the partnership will focus on developing and clinically evaluating new tools in areas such as remote patient monitoring, AI, and clinical decision support. These innovations will be tested in real-world settings to ensure they deliver measurable value to both patients and healthcare systems. The initiative hopes to benefit patients particularly in remote or underserved regions with limited access to care.

“We are thrilled to deepen our relationship with BIOTRONIK to co-develop digital health solutions that are grounded in clinical evidence and designed with patient welfare at the heart,” said Professor Clara Chow AM, Professor of Medicine, Cardiologist (WSLHD), Academic Director (WARC) & Professor of Medicine at the Sydney Medical School. “It presents a unique opportunity to translate cutting-edge research into real-world impact for people living with cardiovascular disease.”

Cardiovascular disease remains the leading cause of death globally. Addressing this challenge requires cross-sector collaboration to translate research into practical, scalable solutions. This is aimed at accelerating progress, meeting the demands of modern healthcare.

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About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.    

Media Contact

BIOTRONIK Press Office: press@biotronik.com  

About the University of Sydney

As Australia’s first university – founded in 1850 – the University of Sydney has been sharing knowledge, empowering students and addressing the world’s most complex challenges for 175 years. Currently ranked first in Australia (US News) and joint 25th in the world (QS World University Rankings), we’re consistently placed among the best universities and globally renowned for our teaching and research. Westmead Applied Research Centre (WARC), a Sydney Medical School, Faculty of Medicine & Health Impact Centre, was established by the University of Sydney in collaboration with the Western Sydney Local Health District to create and apply innovation to addressing chronic health conditions. WARC brings together multidisciplinary experts to co-design, evaluate and translate innovative solutions into healthcare and prevention. It partners with industry, government, and not-for-profit organisations.

Media Contact

Luisa Low | Senior Media & PR Adviser
The University of Sydney                                           
Media and Public Relations                   
+61 438 021 390 | luisa.low@sydney.edu.au | sydney.edu.au 

• 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. 

The first procedure on a patient as part of the study was performed at Na Homolce Hospital in Prague, Czech Republic by Prof. Dr. Vivek Reddy, Director, Cardiac Electrophysiology, Mount Sinai Health System, New York, USA. “The procedure using the new ElePulse PFA System was efficient. Its single-shot, single-position design performed well and has real potential to simplify AF ablation workflows,” said Prof. Reddy. 

Prof. Petr Neužil, Head of the Department of Cardiology, Na Homolce Hospital added: “We are proud to enroll the first patient in the study here at Na Homolce Hospital. As a center committed to research, we are excited to help validate a promising next-generation PFA technology.” Today, PFA has emerged as one of the most advanced technologies in cardiac electrophysiology, offering a non-thermal alternative to traditional ablation methods.  

The ElePulse PFA System combines a 3D spiral multi-electrode catheter with a compact PFA generator. It delivers donut-shaped pulsed fields for durable, transmural pulmonary vein isolation and contiguous ring-shaped ablations beyond the veins—all without catheter repositioning. The system integrates seamlessly with standard 8.5F sheaths and widely used 3D mapping platforms, minimizing workflow disruption, reducing setup complexity, and training needs.  

In the first-in-human cohort of 36 patients¹, ElePulse achieved: 

• 100% acute pulmonary vein isolation
• 92% freedom from AF at 12 months
• No thermal-related complications 

Dr. Petr Peichl, Principal Investigator and Cardiac Electrophysiology Specialist at the Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic noted: “ElePulse provided true single-shot ablations that were fast, effective, and well-tolerated by patients. This study will help us evaluate the system’s ability to deliver durable AF treatment without catheter repositioning, greatly contributing to streamlining workflows.” 

“RESET-AF 3D reflects our commitment to advancing cardiac electrophysiology through meaningful innovation,” said Andreas Hecker, President CRM/EP at BIOTRONIK. “ElePulse represents a major step forward in establishing PFA as a transformative technology in AF with simpler, faster, safer treatment for patients.” 

One of the few companies in Europe with focal PFA expertise, BIOTRONIK’s expansion into single-shot PFA builds on its leadership as a significant player in the fastest-growing segment of AF treatment. The RESET-AF 3D study lays the foundation for CE Mark approval and market release of ElePulse, reinforcing BIOTRONIK’s commitment to delivering value-adding, patient-centric solutions. 

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References 

1 Gould, Paul A. et al. First-In-Human Experience from the RESET-AF Trial: The 6- and 12-Months Outcomes of PVI Using a Novel Single-Shot Pulsed Field Ablation System. Presented at: APHRS 2024 in Sydney. 

About BIOTRONIK  

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.