Abbot receives CE mark for heart rhythm management devices

19 February 2020 (Last Updated February 19th, 2020 11:10)

US-based health care and medical device company Abbott has secured CE Mark for its Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices in Europe.

Abbot receives CE mark for heart rhythm management devices
Abbott gets approval in Europe for its next-generation heart rhythm management devices in featuring patient app and bluetooth connectivity. Credit: Abbott.

US-based health care and medical device company Abbott has secured CE Mark for its Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices in Europe.

The devices are intended for patients with abnormal heart rhythms and heart failure.

The Gallant system, paired with Abbott’s myMerlinPulse mobile app, offers increased patient engagement and helps to streamline communication.

The app helps physicians to remotely monitor their patients and identify asymptomatic cases or patient-triggered transmissions.

Patient engagement and remote monitoring also become possible because of smartphone connectivity and connected applications.

Other benefits provided by the devices include a patient preferred design, MRI compatibility and improved battery longevity.

Abbott’s Cardiac Rhythm Management business chief medical officer and divisional vice president Avi Fischer said: “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 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.”

Gallant CRT-D system comes with Abbott’s MultiPoint Pacing and SyncAV features that aid patients to respond to CRT therapy.

Abbott’s TailoredTherapy is included in the Gallant ICD device to help physicians more intuitively programme their patient’s devices.

The company claims that the latest cybersecurity controls, included in both the Gallant devices, allow patients to seamlessly and securely update the device.