Archive | BIOTRONIK

BIOTRONIK - Archive

2020
23
June
2020
| 18:01 Europe/Amsterdam
Hoje, a BIOTRONIK anunciou o seu compromisso de fornecer aos médicos ferramentas adicionais para estimular o feixe de His, coincidindo com o lançamento imediato das ferramentas de Estimulação do feixe de His (HBP) em um número limitado de centros, co...
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23
June
2020
| 17:57 Europe/Amsterdam
BIOTRONIK ha anunciado hoy su compromiso de propocionar a los médicos herramientas adicionales para la estimulación del haz de His, coincidiendo con el lanzamiento de estas herramientas para la estimulación hisiana (HBP, por sus siglas en inglés) en ...
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19
June
2020
| 20:50 Europe/Amsterdam
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 cyb...
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16
June
2020
| 12:50 Europe/Amsterdam
BIOTRONIK has today announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP) tools in a limited number of centers starting now with a full launch later in 2020...
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20
May
2020
| 16:00 Europe/Amsterdam
BIOTRONIK and Acutus Medical today announced a new alliance to provide a comprehensive portfolio of electrophysiology, mapping, ablation and accessory products for catheter-based treatment of cardiac arrhythmias across select markets, including Europ...
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13
May
2020
| 13:30 Europe/Amsterdam
Results just published in Circulation Arrhythmia and Electrophysiology confirm that BIOTRONIK Home Monitoring® provides safe and cost-effective remote management of pacemaker patients,1 indicating that it can safely replace the common practice of rou...
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06
May
2020
| 09:24 Europe/Amsterdam
According to recently presented TICO trial data, patients with acute coronary syndrome (ACS) treated with BIOTRONIK’s Orsiro® drug eluting stent (DES) benefit from stopping aspirin three months after stenting and continuing only with ticagrelor monot...
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31
March
2020
| 10:18 Europe/Amsterdam
As the COVID-19 pandemic continues, we are conscious of the enormous strain that you are all under. We share your concerns about the spread of the virus and the disruption it is causing globally. We are doing what we can to help minimize this disrupt...
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04
March
2020
| 14:02 Europe/Amsterdam
The US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communic...
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24
February
2020
| 00:00 Europe/Amsterdam
BIOTRONIK today announced three-year data from the BIOFLOW-V trial, which was presented yesterday at the 2020 CRT Congress. The three-year follow-up data demonstrates consistently lower clinical event rates and improvement in patient outcomes, reinfo...
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21
February
2020
| 14:11 Europe/Amsterdam
BIOTRONIK has announced CE Mark certification for the Orsiro® Mission drug-eluting stent (DES) system. The next generation of the company’s ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents.1 Orsiro Mission is n...
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27
January
2020
| 00:00 Europe/Amsterdam
BIOTRONIK, Inc. today announced the appointment of David Hayes, MD, FACC, as Chief Medical Officer. Dr. Hayes will oversee the development of BIOTRONIK’s cardiovascular solutions with a focus on advancing unique, proven innovations that help physicia...
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23
January
2020
| 00:00 Europe/Amsterdam
BIOTRONIK this month announced the market release of its new injectable cardiac monitor (ICM), BIOMONITOR III. The novel device is designed to help patients with irregular heart rhythms by documenting unexplained syncope with increased clarity. As...
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2019
30
October
2019
| 00:00 Europe/Amsterdam
BIOTRONIK announced today that its Orsiro® coronary drug-eluting stent (DES) has been approved for sale in China by the National Medical Products Administration. The company expects to make the device available to Chinese patients and physicians in t...
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04
October
2019
| 15:31 Europe/Amsterdam
On October 1, the US Food and Drug Administration (FDA) issued a Safety Communication regarding a set of cybersecurity vulnerabilities, referred to as “Urgent/11” that — if exploited by a remote attacker — may introduce risks for medical devices and ...
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30
September
2019
| 00:00 Europe/Amsterdam
Full cohort data from the BIOSOLVE-IV registry strengthen the clinical evidence for BIOTRONIK’s Magmaris®1 Resorbable Magnesium Scaffold (RMS) as a therapy option for patients with coronary artery disease. Dr. Stefan Verheye, Senior Interventional Ca...
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18
September
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced that it is the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, BIOTRONIK also obtained...
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11
September
2019
| 00:00 Europe/Amsterdam
Twelve-month results of the BIOFLEX COF trial have demonstrated that the implantation of stents with low chronic outward force1 (COF) was associated with less neointimal hyperplasia2, consequently resulting in less restenosis. Patients treated with B...
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02
September
2019
| 00:00 Europe/Amsterdam
BIOTRONIK’s ultrathin Orsiro® stent demonstrated superiority over Xience with respect to target lesion failure (TLF) at 12 months, according to newly released data from the BIOSTEMI trial.1 Today Dr. Juan Fernando Iglesias, Geneva University Hospital...
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12
August
2019
| 15:37 Europe/Amsterdam
The work ‘Security Testing of the Pacemaker Ecosystem’ was recently published as a master’s thesis, authored by Mr. Anders Been Wilhelmsen and Mr. Eivind Skjelmo Kristiansen. This publication investigates the state of cybersecurity of BIOTRONIK’s ICS...
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31
July
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced the company’s PK Papyrus® covered coronary stent system1 has been named a finalist in the 2019 Prix Galien USA Awards Ceremony for Best Medical Technology. PK Papyrus is used in emergency situations to create a physical b...
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22
July
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced the publication of the SENSE Trial results in the Journal of Cardiac Electrophysiology, proving BIOTRONIK’s DX system is equivalent to dual-chamber implantable cardioverter defibrillators (ICDs) in detecting atrial high-rate...
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08
July
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatme...
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28
June
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced the market release of its new injectable cardiac monitor (ICM), BIOMONITOR III, following approval in the CE region. The novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhyth...
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07
June
2019
| 00:00 Europe/Amsterdam
New data from the BIOSOLVE-IV registry strengthen the clinical evidence for the Magmaris®1 resorbable scaffold device and procedure success and safety profile at one year. Dr. Stefan Verheye, Senior Interventional Cardiologist at Antwerp Cardiovascul...
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27
May
2019
| 00:00 Europe/Amsterdam
BIOTRONIK announced today that the first patient for the BIO|MASTER.Cor Family study was enrolled at Pauls Stradins Clinical University Hospital in Riga, Latvia at the cardiology department led by Prof. Andrejs Erglis. The patient received a Rivacor ...
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21
May
2019
| 00:00 Europe/Amsterdam
Focusing on patients with small vessels, three-year outcomes of the BIO-RESORT randomized controlled trial (RCT) showed a significantly lower target lesion revascularization (TLR) rate and thus better efficacy of the Orsiro® drug-eluting stent1 (DES)...
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08
May
2019
| 00:00 Europe/Amsterdam
Heartbeat International (HBI) Foundation President Dr. Benedict S. Maniscalco will be honored with the Heart Rhythm Society (HRS) Global Humanitarian Award at this year’s Scientific Sessions. Dr. Maniscalco, the first-ever recipient of this award, is...
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06
May
2019
| 00:00 Europe/Amsterdam
BIOTRONIK today announced initial enrollment into the BIO-LIBRA study, a first-of-its kind, large-scale prospective study to analyze sex-specific outcomes in patients with non-ischemic cardiomyopathy (NICM) treated with cardiac defibrillator device t...
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06
May
2019
| 00:00 Europe/Amsterdam
The observational THORN registry1 highlights the importance of rapid corrective action by medical staff in cases of inappropriate diagnosis and therapy using implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibri...
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