Abbott wins CE Mark for ICD device

Abbott (NYSE:ABT) this week announced it received CE Mark for its Gallant implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillator devices.
The Gallant ICD and CRT-D devices feature Bluetooth connectivity and an accompanying smartphone app to enable patient engagement and remote monitoring. The devices also feature improved battery longevity and MRI compatibility.
ICDs are often recommended to prevent sudden cardiac death in patients who have reduced cardiac function and could be at risk of suffering abnormal heart rhythms. CRT-Ds are also used to prevent sudden death but can restore the normal timing of the ventricles or lower chambers of the heart.
Abbott’s Gallant system is paired with the company’s myMerlinPulse smartphone app for better communication between doctors and patients. The app also allows physicians to monitor patients remotely to identify asymptomatic episodes and patient-triggered transmissions.
“The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system,” divisional VP and chief medical officer of the cardiac rhythm management business Avi Fischer said in a news release. “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 also includes Abbott’s MultiPoint Pacing and SyncAV to help patients respond to CRT therapy better.
“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,” Johannes Sperzel, head of electrophysiology at the Kerckhoff Klinik in Germany, said. “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. The features in Abbott’s devices will propel the industry forward in a very meaningful way.”
Original Article: (https://www.massdevice.com/abbott-wins-ce-mark-for-icd-device/)