BIOTRONIK Opens New Asia-Pacific Hub in Singapore New Asia-Pacific Hub Strengthens Singaporean MedTech Ecosystem

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

BIOTRONIK, die 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

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

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 BIO|WOMEN 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

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

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

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

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 announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress. The randomized controlled non-inferiority trial evaluated the safety and efficacy of the Passeo®-18 Lux® drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic), and showed excellent results for both balloons through 24 months. 1 The prospective, multicenter, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with

BIOTRONIK announced the CE approval and first European implant of its latest insertable cardiac monitor (ICM). The BIOMONITOR IV features artificial intelligence (AI) for false positive reduction. It is the only ICM on the market with premature ventricular and atrial contraction (PVC and PAC) discrimination capabilities, 1,2 as well as industry-leading signal quality and transmission success for highly reliable remote patient management. 3 False positive detections may take clinicians a considerable amount of time to review. That’s why BIOMONITOR IV features SmartECG, an intelligent system

Following the recent CE approval of the Solia S lead 1 for LBBAP, BIOTRONIK proudly announces the world’s first and only complete CSP system, now fully CE-approved for Left Bundle Branch Area Pacing (LBBAP). 2 The BIOTRONIK CSP system comprises three proven components: Selectra 3D catheters offering exceptional handling 3, Solia S leads – the most popular choice of stylet-driven leads for LBBAP 4 providing enhanced stability 3, and the Amvia pacemaker family, the first and only family approved for LBBAP. 2 Notably, this groundbreaking system is the world’s first and only approved MR

BIOTRONIK, a leading global medical technology company specializing in innovative cardiovascular and endovascular solutions, proudly announces a multinational distribution partnership with Texray, the pioneering developer of a groundbreaking radiation protection textile. In this collaboration BIOTRONIK will distribute Texray's head and neck protectors starting in selected European and Middle Eastern countries. Both partners aim to raise awareness about the critical importance of radiation protection for healthcare professionals, who serve in environments where radiation exposure is an inherent

BIOTRONIK has been granted Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve™ below-the-knee resorbable magnesium scaffold (BTK RMS). The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs. 1 To qualify for a Breakthrough Device Designation, a device

BIOTRONIK is pleased to announce the release of the results of the BENEFIT-01 study published in Neuromodulation. 1 The prospective, multi-center study was designed to investigate the influence of clinically relevant Spinal Cord Stimulation (SCS) parameters on patient perception. BENEFIT-01 marked the beginning of a series of SCS clinical studies with the aim of developing an SCS technology that provides sustained pain relief with few side effects. From July to November 2017, 40 patients with low back and/or leg pain who had completed a commercial SCS trial were enrolled at seven clinical

In a recent prospective, international, multicenter, nonrandomized trial, the BIO|MASTER.Selectra 3D study assessed the performance and safety of BIOTRONIK’s Selectra 3D guiding catheter, revealing compelling insights into its ease of handling and effectiveness. Conducted across 10 centers in Australia, Hong Kong and Europe, the study included 157 patients who underwent a CSP procedure for bradycardia pacing or heart failure indications. The results of this research have been published in the Heart Rhythm O 2 journal. 1 Key Findings of the BIO|MASTER.Selectra 3D Study: High Success Rate in

BIOTRONIK is proud to introduce the Micro Rx™ catheter, a novel rapid exchange microcatheter developed to easily enhance guidewire support during percutaneous coronary interventions (PCI). This cutting-edge device, exclusively distributed by BIOTRONIK, is manufactured by IMDS (Interventional Medical Device Solutions). Micro Rx catheter marks the fourth IMDS product BIOTRONIK has brought to the U.S., creating a compelling portfolio of devices which includes NHancer Rx, TrapIT, and ReCross catheters. The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers of

BIOTRONIK announced the milestone achievement of 100,000 implanted single-chamber implantable cardioverter-defibrillators (ICDs) equipped with DX Technology. Since the introduction of this unique technology in 2009, clinicians in more than 80 countries across all continents use DX ICDs. “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’

BIOTRONIK announces the CE approval and launch of Freesolve™ Resorbable Magnesium Scaffold (RMS). This third generation RMS has been engineered to provide optimized vessel support, yet achieves magnesium resorption within 12 months. 1 The new Freesolve RMS is a groundbreaking vascular advancement based on reliable clinical evidence. Recent BIOMAG-I trial data highlights an exceptional 99.3% magnesium strut degradation 12 months after implantation 2, consistent performance, regardless of lesion characteristics, and restoration of vasomotion. 3 "Having closely observed the evolution of