FDA approves Abbott s Bluetooth connected pacemaker, defibrillator implants
Abbott has secured approvals from the FDA for its new generation of connected pacemakers and defibrillator implants.
The company’s Gallant line—including an implantable cardioverter defibrillator and a cardiac resynchronization therapy defibrillator—features Bluetooth technology, linking the devices with a personal smartphone app to help monitor patients with potentially life-threatening heart arrhythmias.
After pairing the device with Abbott's myMerlinPulse software, patients and their clinicians can access data tracking the implants’ performance and event history. Care teams can also monitor patients remotely to identify episodes that may occur without any symptoms, the company said.
The MRI-compatible Gallant devices were launched in Europe this past February after Abbott received a CE mark.
"The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system," Abbott’s chief medical officer for its cardiac rhythm business, Avi Fischer, said at that time.
"Abbott's new Gallant system provides people the ability to connect to their doctor anytime, even while away from home, and reinforces our commitment to incorporate advanced technologies that will help improve engagement between patients, caregivers and doctors," Fischer added. The resynchronization implant also incorporates pacing and other features that can be digitally tailored to an individual patient.