BIOTRONIK’s DX Technology Reaches Significant Milestone: 100,000 DX Devices Implanted Clinicians Recently Performed the 100,000th Procedure Implanting an ICD Equipped with DX Technology – the World’s Only Single-Lead ICD System Providing Direct Atrial Sensing

BIOTRONIK announced the milestone achievement of 100,000 implanted single lead implantable cardioverter-defibrillators (ICDs) equipped with DX Technology enabling direct atrial sensing for atrial fibrillation (AF) detection and monitoring. Since the introduction of this unique technology in 2009, DX ICDs are used today by clinicians in more than 80 countries around the world.

“Reaching this significant milestone, BIOTRONIK stands as a proud pioneer and partner in cardiac rhythm management. Our commitment to quality and focus on innovation sets us apart, allowing us to introduce meaningful innovations in the market, such as DX Technology, that make a real difference in patients’ lives,” said Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. “This milestone demonstrates our collective efforts and dedication to making a positive difference and helps us define a new standard in patient care.”

What makes DX Technology so distinctive? The incidence of AF in patients with ICDs is approximately 21 percent (mean annual probability),¹ and AF is often undetected – and therefore untreated. Single-chamber ICDs account for a significant proportion of ICDs implanted, which, due to the absence of an atrial lead, cannot provide direct atrial sensing.¹ DX Technology, however, available as a single-lead ICD system equipped with a floating atrial dipole, offers reliable, timely information about atrial arrhythmias and detects AF early.^2-6 After detection, the DX ICD system helps monitor AF burden over time³ so clinicians can intervene when needed, react to changes in patient status and optimize patient treatment. In combination with BIOTRONIK Home Monitoring^®, this AF management solution offers a comprehensive assessment of ICD patients and enables earlier, well-informed decision-making.³

“We are deeply grateful for the trust we’ve received from the medical community. We develop solutions to ease physicians’ workloads and improve patient care through holistic and connected approaches. Our innovations are rooted in trustworthy customer relations, feedback and our extensive expertise in cardiac device implants and leads,” said Dr. David Hayes, Chief Medical Officer, BIOTRONIK, Inc. “With this impressive milestone and the extensive clinical evidence, DX Technology has proven itself, and I am confident that we will reach more milestones such as this in the years to come.”

Over the past decades, more than 20 clinical studies that enrolled over 4,000 patients have confirmed the safety and efficacy of DX Technology. This strong foundation of clinical evidence has recently been enriched by the MATRIX study results, the largest clinical evaluation of DX Technology to date. Results from the MATRIX study confirm under real-world conditions that DX, with Home Monitoring, allows for reliable, guideline-recommended remote monitoring of subclinical AF.

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References:

1. Reinhold T, Belke R, Hauser T, et al. Cost Saving Potential of an Early Detection of Atrial Fibrillation in Patients after ICD Implantation. BioMed Research International, Volume 2018, 14 August 2018, Article ID 3417643.

2. Biffi M, Iori M, De Maria E, et al. The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry. Journal of Cardiovascular Electrophysiology, Volume 31, Issue 4, April 2020, Pages 846–853.

3. Hindricks G, Theuns DA, Bar-Lev D, et al. Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole. EP Europace, Volume 25, Issue 5, May 2023, euad061.

4. Kurt M, Jathanna N, Babady M, et al. Avoiding inappropriate therapy of single-lead implantable cardioverter-defibrillator by using atrial-sensing electrodes. Journal of Cardiovasc Electrophysiology, Volume 29, Issue 12, December 2018, Pages 1682–1689.

5. Thomas G, et al. Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial. J Cardiovasc Electrophysiol. 2019 Oct;30(10):1994-2001.

6. Pung X, Hong DZ, Ho TY, et al. The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new-onset atrial high-rate episodes or subclinical atrial fibrillation: A systematic review and meta-analysis. Journal of Arrhythmia. Volume 38, Issue 2, 15 January 2022, Pages 177–186.