First Implant of Amvia Sky in Europe, the World’s First Pacemaker Approved for LBBAP* BIOTRONIK Announces the Full Market Release of Its Newest Family of Pacemaker and CRT-P Devices, With Patient-Centric Technologies for Better Patient Care and Workflow Simplification
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 pacing-induced cardiomyopathy."
The University Hospital Ghent is the first clinic in Europe to implant an Amvia family system. As the first device certified for left bundle branch area pacing (LBBAP)1, Amvia fosters natural myocardial contraction patterns, designed to help reduce the risk of patients developing pacing-induced cardiomyopathy and its severe consequences. It is also the only system in the market to offer a myocardial contractility sensor and provide physiologic heart rates with Closed Loop Stimulation (CLS). Furthermore, Amvia automates many routine tasks during implantation, in-office follow-ups, remote monitoring, and MRI workflows, helping to reduce the burden of care2.
The Amvia family features BIOTRONIK’s proprietary MRI Guard 24/7 technology, which uses always-on, dedicated sensors to automatically recognize when a patient enters an MRI field and then converts the device to MRI mode. The device returns to its permanent programming following the completion of the scan, eliminating any pre- or post-scan programming needs.3,4
“MRI Guard 24/7 presents a practical answer to real-life obstacles, aiming to enhance safety and efficiency for patients with CIED who require MRI access,” said Prof. De Pooter. “The goal is to make the MRI process as seamless as possible, not just for patients but also for caregivers in the device clinic and MRI suite. By utilizing MRI Guard 24/7, the need for repeated visits to the clinic for pre- and post-programming is eliminated. Additionally, the device's ability to switch to MRI mode only during the scan reduces any potential patient discomfort.”
“We are delighted to witness the successful market release of our latest development. This significant milestone serves as a testament to our ongoing commitment to driving advancements in the cardiovascular market, even after 60 years. Our innovative solutions, such as the Amvia family, continue to improve the lives of patients worldwide,” says Dr. Andreas Hecker, President CRM/EP at BIOTRONIK.
With patient-centric technologies that address both patients’ and caretakers’ needs, Amvia family’s comprehensive capabilities offer unique physiologic treatment, enhanced therapy, and increased workflow efficiency – so that more patients may benefit from more personalized care.
Learn more about Amvia Sky and Amvia Edge here
-END-
References:
*1. BIOTRONIK Amvia Sky technical manual, Medtronic Azure XT DR MRI SureScan™ manual; Boston Scientific Accolade MRI™ technical manual; Abbott Assurity MRI™ user’s manual; MicroPort Alizea™ implant manual.
2. Garcia-Fernández FJ, Asensi JO, Romero R, et al. Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). Eur Heart J. 2019; 40(23): 1837–1846.
3. Data on file.
4. Mullane S, Michaelis K, Henrickson C, et al. Utilization and programming of an automatic MRI recognition feature for cardiac rhythm management devices. Heart Rhythm. O2. 2021; 2: 132–137.
Disclaimer:
The LBBAP claim was not submitted and therefore is currently not approved by FDA. The content not intended for US healthcare providers.
About BIOTRONIK:
At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.
More Press Releases
-
Image
BERLIN, GermanyPress ReleaseDigital Heart Summit 2024: Pioneering the Future of Cardiology Through Digital Innovation
The Digital Heart Summit 2024, held in Berlin on October 25-26th, concluded with resounding success, bringing together leading minds in eHealth to explore the cutting-edge innovations in digital cardiology. The summit attracted over 100 cardiologists, researchers, and tech innovators from across Europe, making it an excellent platform for interactive exchange and diverse insights in this fast-evolving field. Throughout the two-day event, attendees engaged in discussions on the latest advancements in artificial intelligence, telemedicine, and wearable health devices. These technologies are
-
Image
MONTREAL, CanadaPress ReleaseAmvia Sky Launched in Canada, the World’s First Pacemaker Approved for LBBAP*
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
-
Image
BERLIN, GermanyPress ReleaseB3 Clinical Study Results Reveal that Closed Loop Stimulation (CLS) Rate-Adaptive Pacing Delays Subclinical AF in Sinus Node Disease (SND) patients
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
-
Image
BERLIN, GermanyPress ReleaseBIOTRONIK Introduces New BIOMONITOR IV Insertable Cardiac Monitor with Artificial Intelligence at EHRA Congress 2024
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
-
Image
BERLIN, GermanyPress ReleaseBIOTRONIK Introduces World’s First and Only System CE Approved for Left Bundle Branch Area Pacing (LBBAP)
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
-
Image
BERLIN, GermanyPress ReleaseNew BIOlMASTER.Selectra 3D Study Highlights Exceptional Safety and Performance of BIOTRONIK’s Selectra 3D Guiding Catheter for CSP
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
-
Image
BERLIN, GermanyPress ReleaseBIOTRONIK’s DX Technology Reaches Significant Milestone: 100,000 DX Devices Implanted
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’
-
Image
BERLIN, GermanyPress ReleaseREACT DX Registry Highlights Relevance of Atrial High-Rate Episode Remote Monitoring in ICD Patients
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
-
Image
BERLIN, GermanyPress ReleaseBIOTRONIK Receives CE Approval for the World’s First Pacemaker and CRT-P Family Approved for Left Bundle Branch Pacing*
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
-
Image
BERLIN, GermanyPress ReleaseLa tecnología DX demuestra una alta precisión en la detección de la fibrilación auricular (FA) en pacientes con DAI monocameral
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
-
Image
BERLIN, GermanyPress ReleaseBIOTRONIK Conduction System Pacing Tools Received CE Mark for Left Bundle Branch Area Pacing
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