BIOTRONIK Receives CE Approval for the World’s First Pacemaker and CRT-P Family Approved for Left Bundle Branch Pacing*

Dr. Fadi Mansour performed the first Canadian implant of BIOTRONIK’s newest pacemaker and CRT-P generation earlier this year at the Centre Hospitalier de l'Université de Montréal. The patient received an Amvia Sky HF-T QP triple chamber pacemaker device. The first implant follows the full market release of BIOTRONIK’s newest family of pacemaker and CRT-P devices, featuring patient-centric technologies for better patient care and simplified workflows. “The Amvia Sky HF-T QP offers a significant number of advanced features, making it the most complete CRT-P on the market including streamlined

During a Late-Breaking Session at the annual meeting of the European Heart Rhythm Association (EHRA), Dr. Ennio C. L. Pisanò, Vito Fazzi Hospital, Lecce, Italy, unveiled groundbreaking clinical findings from the randomized, multicenter B3 study 1 regarding the impact of CLS on the incidence of Subclinical AF in SND patients. CLS is a unique rate-adaptive algorithm that is able to detect not only movement but emotional stress, physical stress, or physical activity. In essence, CLS is an impedance-based sensor that translates changes in cardiac contractility to increase heart rate –mimicking a

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

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 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’

The first implant in Europe of BIOTRONIK’s latest pacemaker and CRT-P generation was conducted in early August by Prof. Dr. Jan De Pooter at the University Hospital Ghent in Belgium. The patient who received an Amvia Sky dual chamber pacemaker device was a 68-year-old man suffering from paroxysmal AV-block strongly limiting his physical efforts. “The implantation went on straightforward and very smoothly,” commented Prof. De Pooter after the procedure. “LBBAP enables pacing in a very natural, physiological way, benefiting the patient by offering physiological pacing and minimizing the risk for

A recent study highlights that implantable cardioverter-defibrillator (ICD) patients with new-onset atrial high-rate episodes (AHRE) often show high stroke risk while not being on oral anticoagulation (OAC), underlining the relevance of continuous AHRE burden monitoring. 1 The study also reports that the combination of BIOTRONIK’s unique DX ICD system with Home Monitoring is an effective and convenient way to detect AHRE. 1 REACT DX is a prospective, multi-center registry that enrolled 234 de novo ICD patients from 14 centers in Germany. It assessed the incidence of new-onset AHRE in an ICD

Los resultados del estudio MATRIX muestran que la alta precisión en la detección de los sistemas DAI DX con un solo cable para los episodios de FA (99,7 % para episodios ≥1 h), combinada con el potente rendimiento de transmisión de BIOTRONIK Home Monitoring ®, permite la monitorización remota fiable de la FA subclínica recomendada por las guías. Los resultados se publicaron en Europace a principios de esta semana. 1 MATRIX evaluó la utilidad del sistema DAI DX (detección de la señal auricular mediante un dípolo flotante integrado en el cable del DAI) para la monitorización remota de los

BIOTRONIK announced today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium