Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring

AbbottAbbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has approved the company's next-generation Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.

It is estimated that as many as 6.1 million people in the United States battle cardiac arrhythmias, or abnormal heart rhythms,(1) and ICDs are used to help reduce the risks of life-threatening arrhythmias. For patients with heart failure or in situations when the heart's chambers beat out of sync, CRT-Ds can be used to restore the heart's natural pattern of beating.

"We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way," said Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott. "The Gallant devices are the latest example of how Abbott is driving innovation to meet changing healthcare needs and helping to improve connectivity and engagement between patients and their doctors."

The new Gallant system pairs with Abbott's secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously 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 ability for patients to stay connected to their doctors via their implanted device and a smartphone app has the potential to change how healthcare providers and patients communicate with each other," said Raffaele Corbisiero, M.D., FACC, director of electrophysiology and pacing at Deborah Heart and Lung Center, Browns Mills, N.J. "The FDA's approval of Abbott's Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all."

The Gallant system received CE Mark for use across Europe earlier this year.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

1. Centers for Disease Control and Prevent, Atrial Fibrillation. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm. Accessed June 3, 2020.

Most Popular Now

AI Predicts Lung Cancer Risk

An artificial intelligence (AI) program accurately predicts the risk that lung nodules detected on screening CT will become cancerous, according to a study published in the journal Radiology. Lung cancer is...

EU Health Policy Platform Calls for Prop…

The European Commission is inviting public health stakeholders to submit initiatives for anew cycle of Thematic Networks under the EU Health Policy Platform. The purpose of a Thematic Network is...

What Next for Social Care?

Highland Marketing's advisory board welcomed Jane Brightman, social care lead at Institute of Health and Social Care Management, to discuss the sector and its technology needs. A lot of hope...

Philips Introduces the New Spectral Comp…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its newest solution for precision diagnosis with the global introduction of its spectral detector-based Spectral Computed...

Web-Based System Developed to Give Care …

Black Country Pathology Services has worked with CliniSys to create the ICE Portal, a web-based application that makes it easy for care homes, or other community care settings, to be...

Grand Challenge Research Harnesses AI to…

Breast cancer has recently overtaken lung cancer to become the most common cancer globally, according to the World Health Organization. Advancing the fight against breast cancer, the BreastPathQ Challenge was...

UCSF Improves Fetal Heart Defect Detecti…

UC San Francisco researchers have found a way to double doctors' accuracy in detecting the vast majority of complex fetal heart defects in utero - when interventions could either correct...

MEDICA 2021 + COMPAMED 2021: Medical Tec…

15 - 18 November 2021, Düsseldorf, Germany. The date for the globally leading live platforms for the medical technology industry remains a fixed feature in everybody's calendar this year too. The...

New AI Technology Protects Privacy

Digital medicine is opening up entirely new possibilities. For example, it can detect tumors at an early stage. But the effectiveness of new AI algorithms depends on the quantity and...

GP use of Tech Helps Prevent Prescribing…

Academic analysis shows primary care prescribers have been preventing adverse drug reactions, harm and hospital admissions through safer prescribing, after using prescribing tech. The company behind the system also reveals...

Online Survey Successful in Gathering CO…

A pilot project using an online survey to gather data on COVID-19 symptoms received more than 87,000 responses from around the world, providing important insight into the spread of disease...