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Abbott receives CE mark approval for Gallant ICD and CRT-D devices
Abbott has announced that it has received CE mark approval for the Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.
The...
Abbott announces trial to assess new therapy option for stroke
Abbott has announced approval from the US Food and Drug Administration (FDA) for the CATALYST trial to examine its Amplatzer Amulet device compared to...
FDA approves Abbott heart pump for less invasive surgical approach
Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that the...
Battery performance alert and cybersecurity firmware updates for certain Abbott implantable cardiac devices: FDA...
The US FDA has approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk...
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...
Abbott’s Full MagLev HeartMate 3 LVAD receives FDA approval
The FDA has approved the Full MagLev HeartMate 3 (Abbott) left ventricular assist device for use in heart failure patients in need of short-term...
Abbott EnSite Precision™ Cardiac Mapping System ‒ CASE REPORTS
Two case reports—from Michael Kwasman, cardiac electrophysiologist, Providence Sacred Heart Medical Center, Spokane, USA, and Rakesh Latchamsetty, cardiac electrophysiologist, University of Michigan Health Center, Ann Arbor, USA—demonstrate...
Abbott receives CE mark for its Confirm Rx insertable cardiac monitor (ICM)
Abbott has announced CE mark and first use of the new Confirm Rx ICM. According to a company release, this is the world’s first smartphone...
US FDA approves Abbott’s FlexAbility Catheter, Sensor Enabled
The FlexAbility Ablation Catheter, Sensor Enabled is designed to improve the versatility and precision during cardiac ablation procedures to treat atrial flutter.
The Sensor Enabled...
Abbott completes the acquisition of St Jude Medical
Abbott has now completed the acquisition of St Jude Medical. The Abbott press release announcing the completion of the acquisition said, “The transaction provides...
Abbott announces positive results for FIRM-guided rotor ablation at CARDIOSTIM 2016
Abbott has announced positive results from three clinical studies investigating the benefits associated with focal impulse rotor modulation (FIRM)-guided rotor ablation for atrial fibrillation.
The...
Abbott to acquire St Jude Medical
Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure...
Abbott acquires Kalila Medical
Kalila Medical has a novel steerable sheath that is designed to help physicians more easily access and perform catheter-based electrophysiology procedures.
Abbott and GE Healthcare announce agreement to improve atrial fibrillation treatment
The agreement will bring real-time, patient-specific heart electrical activity data to cardiac electrophysiology labs around the world to speed up the diagnosis of the sources of atrial fibrillation and other heart rhythm disorders.
Abbott completes acquisition of Topera
Abbott has acquired all outstanding equity of Topera for US$250m upfront, plus potential future payments tied to performance milestones.
Abbott to acquire Topera and Advanced Cardiac Therapeutics
Abbott enters the catheter-based electrophysiology market with the announcement of an agreement to purchase Topera and the securement of the rights to purchase Advanced Cardiac Therapeutics (ACT). Both companies develop electrophysiology technologies for the diagnosis and treatment of heart rhythm disorders.
Leadless pacing shows high rate of success at six months
Almost 70% of patients treated with a leadless left ventricular (LV) endocardial pacing system had a favourable clinical response at six months, a post-market...
Novel device “safely obliterates” left atrial appendage with minimal amount left behind
The novel left atrial appendage (LAA) closure device Appligator (Append Medical) was a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular...
First patient enrolled in PREDICT-LAA clinical trial
FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial.
The trial is led by Righshospitalet (Copenhagen, Denmark) and aims...
Leading electrophysiologists identify four key studies that will shape arrhythmia treatment in 2020
Leading electrophysiologists have pinpointed four clinical studies due to report findings in 2020—AMULET IDE, aMAZE IDE, PULSED AF and CEASE AF—that they expect to...
The Advisor HD Grid Mapping Catheter, Sensor Enabled, maps at high resolution and is...
Disclaimer: This advertorial is sponsored by Abbott
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (SE), is a unique mapping catheter that, when used with...
Confirm Rx ICM allies with SharpSense technology and syncs to a smartphone for a...
Disclaimer: Advertorial sponsored by Abbott
Launched in May 2019 by Abbott, the next-generation Confirm Rx™ insertable cardiac monitor (ICM) has both the CE Mark in...
AtriCure agrees to buy LARIAT developer SentreHEART
AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial...
ESC 2019: Left atrial appendage closure is non-inferior to NOACS for preventing neurological events
At the 2019 European Society of Cardiology (ESC) Congress (31 August–4 September, Paris, France), Pavel Osmancik (Charles University and University Hospital Kralovske Vinohrady, Prague,...
Low rates of device-related thrombus found with Amplatzer Amulet occlusion device
Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the Amplatzer Amulet device (Abbott) was “infrequently” observed according to a report published in...
New option available for physicians treating patients with atrial fibrillation
Approval has been granted for Abbot’s TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is helping more physicians integrate ablation with 3D mapping to...
The first 60 years of cardiac pacing
Sixty years ago, the first pacemaker implant was made in Stockholm, Sweden (Senning & Elmqvist) on 8 October 1958. The patient had atrioventricular block...
First US clinical study to assess ablation for monomorphic ventricular ablation initiated
Abbott has announced the start of LESS-VT—the first US clinical trial to evaluate the safety and effectiveness of ablation treatment for patients with monomorphic...
US FDA approve HeartMate 3 heart pump advanced heart failure patients not eligible for...
The HeartMate 3 left ventricular assist device has received US FDA approval as a destination therapy for people living with advanced heart failure. With...
Atrial fibrillation related to PFO closure occurs early and is transient
A new meta-analysis of patients undergoing percutaneous closure of patent foramen ovale (PFO) after cryptogenic shock supports previous studies that indicate PFO closure is...
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...
Case report: Mapping a complex macroreentrant atrial arrhythmia in congenital heart disease after surgical...
This article has been sponsored by Abbott
Case description
A 31 year-old female with tricuspid atresia and normally related great vessels who underwent an atriopulmonary Fontan...
Cybersecurity safety communications for implantable cardiac devices: Year in review
Cyber security has become a hot topic in recent years. Leslie Saxon writes in Cardiac Rhythm News about the cybersecurity risks for implantable cardiac...
LVAD technology improves, providing better, longer-term outcomes
This article was sponsored by Abbott.
Left ventricular assist devices (LVAD) are mechanical pumps that are implanted inside a person's chest to help their weakened...
HeartMate 3 left ventricular assist system: Class I recall
The US FDA has issued a class I recall due to a malfunction in the device’s outflow graft assembly that may cause the outflow...
Advisor HD Grid mapping catheter, sensor enabled, gains FDA clearance
Abbott has announced US Food and Drug Administration (FDA) clearance of the Advisor HD Grid mapping catheter, sensor enabled. Advisor HD Grid employs a new...
Short-term DAPT is feasible for patients undergoing percutaneous LAA closure
Felix Weise (Cardioangiologisches Centrum Bethanien, Frankfurt, Germany) and others report in EuroIntervention that a strategy of six weeks’ duration of dual antiplatelet therapy (DAPT)...
LEADLESS: Miniature pacemaker effective at three years, but battery to be redesigned
A miniature leadless pacemaker was safe and effective at three years in the first-in-human LEADLESS study, according to a research letter published in Circulation. However,...
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...
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...
Smartphone compatible ICM launches in USA
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...
3T MRI CE mark announced for 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...
FDA approval for MRI-compatibility for Ellipse ICD
Abbott has received US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for one of the company’s most widely-used implantable cardioverter...
Three studies support efficacy of PFO closure for reducing risk of recurrent stoke
The results of CLOSE, Gore Reduce and the extended follow-up of RESPECT—all published in The New England Journal of Medicine—indicate that percutaneous closure of...
US trial to evaluate safety and efficacy of Amplatzer for patent ductus arteriosus
Abbott has initiated a US pivotal clinical study evaluating the safety and effectiveness of a modified version of its Amplatzer device to correct patent...
Repeat ablation with contact force sensing “does not necessarily guarantee a successful outcome” in...
Preliminary results from the ABLATOR observational registry have shown similar success rates (around 58%) in first time ablation and repeat ablation for persistent atrial...
Europace 2017: Thrombus formation on left atrial appendage occlusion devices strongly associated with higher...
A French multicentre analysis of left atrial appendage (LAA) occlusion for stroke prevention in atrial fibrillation patients has found a 5.3% rate of thrombus...
ACC 2017: Real-world study supports the effectiveness of the CardioMEMS HF system in reducing...
A study outside the clinical trial setting, which included US Medicare patients, has shown the effectiveness of the CardioMEMS HF system (Abbott) to significantly...
Occlutech left atrial appendage occluder shows high procedural success in first-in-man experience
The first-in-man study exploring the safety, feasibility and neurological outcome with the Occlutech left atrial appendage (LAA) occluder (Occlutech) has shown a 93% procedural...
US FDA approves Assurity MRI pacemaker
Abbott has announced US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for both the Assurity MRI pacemaker and the Tendril...
AF Symposium 2017: Use of intracardiac echocardiography is a “viable option” for Amplatzer Amulet...
Intracardiac echocardiograpy (ICE) facilitates a high success implant rate of the Amplatzer Amulet left atrial appendage (LAA) occluder (St Jude Medical/Abbott) as well as...
JACC retracts OASIS trial paper
The Journal of the American College of Cardiology (JACC) has retracted the paper titled: “Impact of rotor ablation in non-paroxysmal atrial fibrillation patients: Results...
New alliance for heart failure calls for improved care for condition
A coalition of charities, patient groups, professional bodies and healthcare companies with an interest in heart failure has been established to raise the profile...
First randomised trial shows “poor outcomes” with rotor ablation
OASIS, the first randomised, controlled, multicentre clinical trial to compare rotor-only ablation with two other ablation strategies in non-paroxysmal atrial fibrillation patients found “poor...
Less than 10% of eligible older patients receive an ICD after a myocardial infarction
Sean D Pokorney (Durham, USA) and others report in JAMA that only 8.1% of older patients who are eligible to receive an implantable cardioverter defibrillator (ICD) after a myocardial infarction actually do so. The authors also found that older age did not appear to affect the mortality benefit that is associated with ICD implantation.
Shalom Jacobovitz Named CEO of American College of Cardiology
On 22 April, the board of trustees of the American College of Cardiology (ACC) announced that Shalom "Shal" Jacobovitz has been selected as the college's chief executive officer.
Computer software monitoring detects ICD malfunctions sooner
A software monitoring program that tracks implantable cardioverter-defibrillator (ICD) function could detect devices' malfunctions earlier than current monitoring processes, according to new research published in Circulation: Cardiovascular Quality and Outcomes.
