Abbott Laboratories Articles
Flash glucose monitoring system now approved in the US
Abbott has announced that the FDA has approved the FreeStyle Libre 14 day Flash Glucose Monitoring system, which allows people with diabetes to wear the sensor up to 14 days with high accuracy. This approval makes Abbott's revolutionary continuous glucose monitor (CGM) the longest lasting self-applied personal glucose sensor available on the market.
Advanced mapping catheter receives FDA clearance
Abbott has announced FDA clearance of the Advisor HD Grid Mapping Catheter, Sensor Enabled. Advisor HD Grid employs a new design that allows physicians to see things differently, capturing and analysing data in a novel manner to create highly detailed maps of the heart that better differentiate healthy from unhealthy tissue.
The world’s smallest mechanical heart valve for paediatric patients
Abbott has announced the FDA approved the Masters HP 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a paediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of childr...
Advisor HD Grid mapping catheter cleared in Europe
Abbott has announced CE Mark approval for the company's new Advisor HD Grid Mapping Catheter, Sensor Enabled, a product designed to advance cardiac mapping during cardiac ablation to treat patients with complex cardiac arrhythmias.
Rx implantable cardiac monitor connects to smartphones
Abbott has secured U.S. FDA clearance for the Confirm Rx Insertable Cardiac Monitor (ICM), the world's first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With FDA clearance Abbott can now provide U.S. patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their health care.
Drug-eluting coronary stent released in Europe
Abbott has announced it received CE Mark for XIENCE Sierra, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. CE Mark allows sale of the device in the European Union and other countries that recognise CE Mark. Advances in this generation of XIENCE — which is known for its exceptional safety — include new features that make it easier for cardiologists to successfully complete complex ...
DRG system helps patients battling complex regional pain syndrome
Abbott has announced the U.S. launch of the company's Proclaim DRG Neurostimulator System, a new device designed to deliver stimulation to the dorsal root ganglion (DRG) and alleviate pain in patients suffering from complex regional pain syndrome (CRPS) of the lower limbs. With the Proclaim DRG system, Abbott has added new, patient-centric benefits to a device capable of delivering the company's sustained and superior pain relief for patient...
Glucose monitoring system receives FDA Approval
The U.S. Food and Drug Administration has approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin&rsquo...
Ellipse ICD receives FDA Approval
Abbott has announced FDA approval for magnetic resonance (MR)-conditional labeling for one of Abbott's most widely-used ICD and associated high voltage leads. The approval of MR-conditional labeling for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads adds another patient-centric benefit to the device and will help further improve access for patients suffering from abnormally fast heart rhythms who ...
Pacemaker firmware update addresses vulnerabilities
Abbott has notified physicians of updates to its implantable pacemakers and defibrillators as part of its ongoing commitment to continuously improve patient care. The new device updates include a Battery Performance Alert for our implantable cardioverter defibrillators (ICDs) that provides physicians with earlier warning of the potential for the low risk of premature battery depletion.
HeartMate 3 LVAD receives FDA Approval
Abbott has announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left Ventricular Assist System (also known as an LVAD). The HeartMate 3 system provides a new option for physicians managing advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge to myocardial recovery).
Cardiac ablation catheter integrates with 3D mapping system
Abbott has announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier for physicians to more effectively treat atrial fibrillation (AF), a condition in which the upper chambers of the heart beat too fast. When integrated with Abbott's EnSite Precision cardiac mapping system, physicians are able to utilise dual impedance and magnetic technologies to help more precisely model the heart.