CE Mark for Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices.- Abbott

Abbott announced it has received CE Mark for the new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices, bringing the most advanced heart rhythm management capabilities along with a new set of benefits to people in Europe with abnormal heart rhythms and heart failure. The devices offer new opportunities for patient engagement and remote monitoring through new smartphone connectivity and connected applications. Additional benefits include a patient preferred design, improved battery longevity and MRI compatibility. Doctors will often recommend ICDs for prevention of sudden cardiac death in patients who suffer from reduced cardiac function and who may be at risk of suffering from life-threatening abnormal heart rhythms. These abnormal rhythms, also known as ventricular arrhythmias, can occur when the heart beats too fast or chaotically leaving the heart unable to pump blood effectively. CRT-Ds are used to prevent sudden death similar to traditional ICDs, but in addition act to restore the normal timing of the ventricles or lower chambers of the heart in patients with reduced cardiac function and progressive heart failure despite optimal medical therapy. Abbott has designed Gallant with a secure lifecycle approach, which includes using the latest cybersecurity controls and partnering with industry cybersecurity experts to provide input into the design and testing of these controls. This approach provides the ability to more seamlessly update the device as cybersecurity threats evolve in the future. Comment: These MRI compatible devices, which Abbott claims have an extended battery lifetime, can securely communicate with patients and physicians via Abbott’s myMerlinPulse smartphone app. Physicians can monitor their patients, including being able to spot asymptomatic events, and patients can trigger their own signals to notify their doctors when they are feeling something abnormal. Patients can also use the app to see what data their doctors are receiving, how the implants are doing, and when to schedule regular appointments.