Press Releases and Statements

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

BIOFLOW-DAPT one-year-data demonstrated non-inferiority and a good safety profile for the Orsiro ® Mission drug-eluting stent (DES) compared to Resolute Onyx DES (p<0.0001) in patients at high risk of bleeding receiving short dual antiplatelet therapy (DAPT). Prof. Marco Valgimigli presented the novel data in a late-breaking trial session at the European Society of Cardiology’s (ESC) Congress in Amsterdam. The results were published simultaneously in Circulation. BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study to assess the safety of one

BIOTRONIK announced the two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by Principal Investigator Prof. Frank Vermassen at CIRSE 2023 in Copenhagen, Denmark. 1 The prospective, international, multicenter post-market registry evaluated the safety and efficacy of the Passeo ®-18 Lux ® drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents. BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, the

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

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

Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for atrial fibrillation (AF) episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring ® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week. 1 MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration

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

Results from the BENEFIT-02 trial – the first of its kind to clinically evaluate a multiphase stimulation paradigm – support the effectiveness of RESONANCE multiphase stimulation used in the BIOTRONIK Neuro Prospera™ spinal cord stimulation (SCS) System in the treatment of patients with chronic pain. In contrast to other currently available SCS therapies, RESONANCE requires less power and uses a proprietary integrated circuit design to deliver a continuous, spatially and temporally distributed therapeutic pulse pattern across the spinal cord. Results of the study were recently published in

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

BIOTRONIK, a leading global medical technology company with 60 years of experience in developing trusted cardiovascular and endovascular solutions, announced today the latest addition to its cardiac rhythm management portfolio. "We are excited to have received CE mark for our newest technology – the world’s first pacemakers and CRT-Ps approved for left bundle branch pacing. Amvia Sky and Amvia Edge represent cutting-edge innovation and incorporate the latest cardiology trends," says Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. In 1963, BIOTRONIK introduced the first German implantable

New data from the BIOMAG-I first-in-human trial shed light on the vascular healing process following the implantation of DREAMS 3G, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS). A detailed intravascular optical coherence tomography (OCT) analysis demonstrated that 99.3% of the struts completely degraded at one year. 1 Dr. Masaru Seguchi from the German Heart Centre in Munich, Germany presented the findings at the European Society of Cardiology’s (ESC) congress in Amsterdam. While earlier BIOMAG-I study results provided favorable outcomes with regards to late lumen loss at