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Cardialen Closes US$17 Million Series B Financing for implantable defibrillator

Cardialen, a medical device company developing a low-energy implantable defibrillation therapy designed to more gently restore normal heart rhythm, has announced the closing of...

Medtronic disables internet updates in CareLink CIEDs due to cybersecurity risks

Medtronic has issued a software update "to address a safety risk caused by cybersecurity vulnerabilities" in 34,000 of their cardiac implantable electronic devices (CIEDs),...

Case report: Usefulness of high resolution mapping with mini-electrodes...

This article has been sponsored by Boston Scientific. Case description A 62-year-old woman, with recent sinus venosus atrial septal defect correction surgery, developed a persistent macroreentrant...

The top 10 takeaways from the 2017 AHA/ACC/HRS guidelines

Sana Al-Khatib
In October 2017, the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) released a guideline document on the management of patients with ventricular...

Integrated mobile monitor allows patients to track five vital signs

Vital USA Inc., a healthcare internet-of-things (IoT) vital sign company announced at the Consumer Technology Association's annual meeting (CES; 9-12 January, Las Vegas, USA) the release...

FDA alert raises concerns over safety of wearable cardioverter defibrillator

The US Food and Drug Administration (FDA) is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may...

FDA mini-sentinel assessment confirms safety and effectiveness of Xarelto (rivaroxaban) amidst...

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced findings from the US Food and Drug Administration's (FDA) mini-sentinel assessment, confirming the positive...

Nearly 25% of chronic ischaemic heart disease patients dead or hospitalised...

  Nearly a quarter of patients with chronic ischaemic cardiovascular disease are dead or hospitalised within six months, reports a European Society of Cardiology (ESC) study...

CMR 2018 announces programme highlights and keynote speakers

  The cardiovascular magnetic resonance (CMR) 2018 meeting organised by European Association of Cardiovascular Imaging and the Society for Cardiovascular Magnetic Resonance will showcase the...

Mobile ECG technology KardioScreen available for universal use

iMedrix, a Silicon Valley and Bangalore-based mHealth start up company, has announced the general availability of its product KardioScreen, a CE certified mobile and...

Novel extravascular substernal pacing as a feasible treatment option for arrhythmias

A study on substernal pacing acute clinical evaluation (SPACE) by Darius Sholevar (Our Lady of Lourdes Medical Center, Camden, USA) et al published in the...

New FDA approvals for Abbott’s MRI-ready devices

Abbott has announced the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for the Quadra Assura MP cardiac resynchronisation therapy...

Positional OSA device obtains national reimbursement in the Netherlands

NightBalance, a Netherlands-based company developing obstructive sleep apnoea (OSA) therapies, has announced that the Dutch National Health Care Institute (ZIN) issued a positive recommendation...

Confirm Rx ICM: Convenient. Connected. Continuous.

This video has been sponsored by Abbott. The Confirm Rx implantable cardiac monitor (ICM) is the world’s first and only insertable cardiac monitor that combines...

Genetic variation “contributes substantially” to AF susceptibility

A recent study by Lu-Chen Weng (Massachusetts General Hospital, Boston, USA) et al which aimed to quantify and systematically characterise the genetic architecture of atrial...

Cardiac contractility modulation device approved in China

Impulse Dynamics' Optimizer device
The Optimizer system developed by Impulse Dynamics has received approval from the China Food and Drug Administration (CFDA). The Optimizer is an implantable cardiac...

Risk of dementia higher without oral anticoagulants for AF

A retrospective national Swedish registry study by Leif Friberg and Mårten Rosenqvist (Karolinska Institutet, Stockholm, Sweden) has found that the risk of dementia is...

Heart Rhythm Society partners with WebMD on AF patient education tool

The Heart Rhythm Society (HRS), in partnership with WebMD Education, has announced the launch of a free online educational tool for atrial fibrillation (AF). The new interactive AF information tool is...

Cluster analysis reveals “considerable heterogeneity” of atrial fibrillation

A cluster analysis of the data from the ORBIT-AF observational registry study has been published by Taku Inohara (Duke University Medical Center, Durham, USA)...

Noninvasive radioablation: Radiotherapy shows 99.9% VT burden reduction

Noninvasive radioablation
A small study by Phillip S Cuculich (Washington University School of Medicine, St Louis, USA) et al has shown that  radiation therapy, commonly used...

AliveCor’s arrhythmia notification technology granted patent

AliveCor has announced the issuance of a US patent which covers the use of data collected from wearable devices as a means of assisting...

Apple and Stanford Medicine launch app-based arrhythmia study

Apple has launched the Apple Heart Study app, a first-of-its-kind research study using Apple Watch’s heart rate sensor to collect data on irregular heart rhythms and...

Imricor announces new developments in MR compatible ablation products

imricor
Imricor is developing a magnetic resonance (MR) compatible injection catheter and has announced a joint development agreement with MiRTLE Medical to integrate MiRTLE’s MR...

Evolocumab becomes first FDA-approved PCSK9 inhibitor for prevention of MI and...

Evolocumab Amgen
Following a priority review by US Food and Drug Administration (FDA), evolocumab has received FDA approval in the USA. The drug is a PCSK9...

FDA clears first medical device accessory for Apple Watch

AliveCor has added another personal electrocardiogram (ECG) technology product to their range, announcing the US Food and Drug Administration (FDA) have cleared the Kardia Band...

New obstructive sleep apnoea diagnostic guidelines favour polysomnography and HSAT

diagnosing obstructive sleep apnoea
The Journal of the American Medical Association (JAMA) have published new guidelines on diagnostic testing for obstructive sleep apnoea (OSA) in adults. The new...

New findings on effects of xenon and hypothermia on cardiac arrest

NeuroproteXeon has announced the publication of a second finding from a randomised, controlled phase II trial of inhaled xenon and oxygen combined with hypothermia...

US$50 million raised for SOLVE-CRT study on wireless CRT technology

EBR Systems has raised US$50 million to conduct the global SOLVE-CRT (stimulation of the left ventricle endocardially) study. SOLVE-CRT is a pivotal clinical trial intended to establish safety...

85% of uninsured patients hospitalised for acute MI face catastrophic costs

Acute myocardial infarction (MI) and stroke patients without medical insurance in the USA face “devastating” and catastrophic health expenses that can bankrupt them, new...

LivaNova pulls out of cardiac rhythm management

LivaNova Microport
LivaNova has entered a binding letter of intent for the sale of its cardiac rhythm management business franchise to Shanghai-based company MicroPort for $190...

Five surprising messages from this year’s Europe AF

Europe AF 2017
1. The "ILL-CONCEIVED" pallas study may be relaunched John Camm "I want to say just a few quick words about dronedarone", John Camm (St George's University of...

Congenital heart disease in children and young adults have 22 times...

  A study published in the Circulation journal has shown that the risk of atrial fibrillation (AF) in young adults and children who suffer from...

Dabigatran consistently shown to decrease risk of brain bleeds compared to...

A new comparative study between dabigatran and warfarin finds similar ischemic stroke risks, but fewer brain bleeds for dabigatron compared with warfarin in US-based...

NOAC reversal agent shows rapid and complete reversal of dabigatran

Boehringer Ingelheim has announced results from two new analyses of the phase III RE-VERSE AD study, which evaluated the safety and efficacy of idarucizumab,...

Rivaroxaban significantly reduces the risk of major amputation by 70% in...

rivaroxaban
Rivaroxaban vascular dose, 2.5 mg twice daily, plus aspirin 100 mg once daily also significantly (p=0.0003) reduces the risk of the composite outcome of...

CPR and emergency cardiovascular care awareness needed for women, children, and...

Presenters at the American Heart Association (AHA)’s annual Scientific Sessions (11-15 November 2017; Anaheim, USA) have identified the lack of awareness of automated external...

New bio envelope designed for S-ICDs launches in USA

bio envelope
Aziyo Biologics has announced the launch of their CanGaroo bio envelope specifically for use with subcutaneous implantable cardioverter-defibrillators (S-ICDs). It is the only cardiac implantable...

Vivek Reddy on the final outcomes of PREVAIL and PROTECT-AF

PREVAIL watchman
Boston Scientific has announced the final five-year outcomes data from the PREVAIL study during a late-breaking clinical trial session at this year’s Transcatheter Cardiovascular...

Pacemakers safely reused in Mexico highlight potential of recycling CIEDs

Recycling or reusing cardiac implantable electronic devices (CIEDs) could bring down costs for low-income or uninsured patients. A small study presented at the 30th...

Northwestern Medicine implement first LVAD with MagLev pump

In Illinois, USA, Jesus Garcia has become the first patient in his state to receive the HeartMate 3 (Abbott/St. Jude Medical) left ventricular assist...

New guidelines on ventricular arrhythmias and sudden cardiac death

The American College of Cardiology (ACC), along with the American Heart Association (AHA) and the Heart Rhythm Society (HRS) has published new guidelines for...

TCT 2017: Artificial intelligence approach to cardiac imaging

Analytics 4 Life, a digital health company applying artificial intelligence to improve and develop existing care pathways, has announced it will be presenting new...

Measuring outcomes after catheter ablations for AF

Published in the Journal of the American College of Cardiology (JACC): Clinical Electrophysiology, Björkenheim et al’s study of patient- and physician-reported outcomes of atrial...

Developing a non-invasive vagus nerve stimulator

aVNS
Nexeon MedSystems has announced its completion of an initial series of clinical studies evaluating the utilization of transcutaneous auricular vagus nerve stimulation (aVNS) for...

Real-time cardiac mapping technology cleared by FDA

Acutus Medical has announced that the US Food and Drug Administration (FDA) cleared the AcQMap high resolution imaging and mapping system as well as...

Low-risk AF for stroke identified with CHA2DS2-VASc Score

A Korean nationwide cohort study by Tae-Hoon Kim et al has shown that truly low-risk Asian patients with atrial fibrillation (AF) for stroke can...

Have you considered this sleeping burden of atrial fibrillation (AF)?

This video has been sponsored by LivaNova. AF is a growing epidemic affecting 33.5 million people today.1 Up to 91% of AF patients have co-morbidities.2 Among...

Smartphone compatible ICM launches in USA

confirm-rx
The US Food and Drug Administration (FDA) has approved Abbott St. Jude Medical’s Confirm Rx insertable cardiac monitor (ICM), a smartphone compatible ICM designed to...

Irregular heartbeat linked to higher thyroid hormone levels

The risk of atrial fibrillation (AF) is increased in subclinical hyperthyroidism, but it has been is uncertain whether variations in thyroid function within the...

FDA updates Class I recall of St. Jude Medical’s ICDs and...

  In October 2016, St. Jude Medical recalled a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to reports of...

Central sleep apnoea treatment device remedē receives FDA approval

Respicardia has received US Food and Drug Administration (FDA) approval of its remedē system, a transvenous implantable neurostimulation device that stimulates the phrenic nerve and...

3T MRI CE mark announced for MRI-compatible pacemaker

MRI-compatible pacemaker
Abott has announced Conformité Européenne (CE) Mark for 3 Tesla (T) magnetic resonance-conditional labelling for both the Assurity MRI pacemaker and the Tendril STS...

Men develop atrial fibrillation earlier than women; extra weight a factor

A study published in the American Heart Association’s journal Circulation has found that men develop atrial fibrillation (AF) about a decade earlier than women on...

Analysis of LAA closure devices reveals post-approval spike in safety events

  A retrospective study conducting a safety assessment and comparison between two percutaneous devices commonly used for left atrial appendage (LAA) closure in the US­...

Use of apixaban prior to cardioversion reduces risk of stroke

According to the results of the EMANATE trial, patients with atrial fibrillation (AF) who receive apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) before undergoing elective cardioversion of...

Catheter ablation lowers mortality in atrial fibrillation patients with heart failure

Catheter ablation of atrial fibrillation significantly reduces mortality and hospitalisation in atrial fibrillation patients with heart failure in comparison with conventional treatment, data from...

Smartphone apps launched for atrial fibrillation patients and their healthcare providers

Two novel smartphone and tablet applications (apps) for atrial fibrillation patients and healthcare professionals have been launched by heart experts. The two apps will...

Left atrial appendage closure during heart surgery protects the brain from...

Closure of the left atrial appendage during open heart surgery protects the brain from infarctions and stroke, and could be routinely performed in the future,...

Cardiac Rhythm News Issue 38 – October 2017 EU edition

Highlights: - Catheter ablation lowers mortality in atrial fibrillation patients with heart failure - Thrombus formation on LAA occlusion devices strongly associated with higher risk of ischaemic...

Sabine Ernst

Sabine Ernst (lead electrophysiology research/consultant cardiologist, Royal Brompton and Harefield Hospital, London, UK and associate lead for Cardiac Imaging in the Biomedical Research Unit...

Cardiac Rhythm News Issue 38 – October 2017 US edition

Highlights: - Catheter ablation lowers mortality in atrial fibrillation patients with heart failure - Thrombus formation on LAA occlusion devices strongly associated with higher risk of ischaemic...

FDA grants marketing clearance for the Peerbridge Cor multi-channel remote ECG...

Peerbridge Health has announced that its first product, the Peerbridge Cor System—a wireless electrocardiogram (ECG) monitor—has received 510(k) clearance from the US Food and...

Boston Scientific announces agreement to acquire Apama Medical

Boston Scientific Corporation has announced a definitive agreement to acquire Apama Medical, a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter...