Abbott receives CE mark approval for Gallant ICD and CRT-D devices

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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 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, Abbott said in a press release.

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.

The new Gallant system pairs with Abbott’s secure myMerlinPulse mobile app to help streamline communication and increase engagement between doctors and their patients. For example, the app allows patients to engage more frequently with their healthcare team by providing access to transmission history and device performance, and the app can prompt patients to schedule their next appointment. Through the myMerlinPulse app, physicians can monitor their patients remotely, allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.

“The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system,” said Avi Fischer, divisional vice president and chief medical officer for Abbott’s Cardiac Rhythm Management business. “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.”

In addition to enhanced remote monitoring capabilities, the Gallant CRT-D system includes Abbott’s MultiPoint Pacing and SyncAV features to help more patients respond to CRT therapy. Also, the Gallant ICD device includes Abbott’s TailoredTherapy suite to help physicians more intuitively program their patient’s devices. By incorporating these features into the Gallant systems, Abbott continues to prioritise therapy built around a patient’s specific programming needs to ensure they respond to treatment in the most effective way.

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.

“As I consider the next generation of high voltage therapy, cardiac rhythm management devices have to become more than just a device – they need to fit people’s lifestyles and empower them to be more engaged with their care and more connected to me and my hospital,” said Johannes Sperzel, head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany, “With Abbott’s new Gallant devices, I can offer my patients smartphone connectivity, powerful connections to their clinical team and improved outcomes through a more tailored therapy approach.”

Abbott’s Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices do not yet have US Food and Drug Administration (FDA) approval.


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