The U.S. FDA has given its nod to Abbott Laboratories' next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The Gallant system pairs with Abbott's secure Mymerlinpulse, an iOS- and Android-compatible mobile smartphone app that aims to streamline communication between doctors and their patients.

Citing statistics from the CDC, the company said that as many as 6.1 million people in the U.S. battle cardiac arrhythmias. ICDs aim 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.

With the FDA’s approval, the app gives individuals access to data, device performance, and transmission history. At the same time, physicians can monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, permitting earlier interventions.

Raffaele Corbisiero, director of electrophysiology and pacing at Deborah Heart and Lung Center in Browns Mills, N.J., praised the move. "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," Corbisiero added.

When asked about the product’s rollout, Abbott, of Abbott Park, Ill., told BioWorld that a full-market release is in the works for later in the year. And it’s aiming to repeat what it has seen in other markets.

"We have had a very positive response across several countries in Europe and in India to the new features including the remote monitoring through smartphone connectivity and the best ratio of size/power and longevity,” the company replied when asked about reactions in other markets.

The company reported Feb. 18 that it had received the CE mark for these offerings. At the time, it noted that the Gallant CRT-D system includes Abbott's Multipoint Pacing and SyncAV features to help more patients respond to CRT therapy. Meanwhile, the ICD device includes the company’s Tailoredtherapy suite to help physicians program their patient's devices.

With this latest regulatory nod, the company described to BioWorld the Gallant devices’ unique features, offering next-generation remote monitoring with Bluetooth technology, while also highlighting the accompanying app. “In addition, the devices feature a new smaller size/shape without compromising on battery longevity or compatibility with magnetic resonance imaging. “

It also noted that there is no fee associated with the Mymerlinpulse app.

During the company’s April 16 first-quarter earnings call, Robert Ford, Abbott’s president and CEO, highlighted the CE marks obtained for several products in the cardiovascular device area, including Gallant. Other products were Triclip, a minimally invasive device for repairing a leaky tricuspid heart valve, and Tendyne, a device for mitral heart valve replacement. The company has scheduled the release of its second-quarter 2020 financial results July 16, before market open.

Other wins

Beyond these regulatory wins, the company has seen several victories in the past few weeks. While it helped in the fight against the current pandemic with its diagnostics, it also reported June 15 that it had won the FDA’s nod for Libre 2 for adults and children with diabetes, ages 4 and older.

Analysts saw great hope for the company with the action. “While approval is a year later than originally expected, the next-gen sensor strengthens an already formidable competitor to the U.S. CGM [continuous glucose monitoring] market featuring real-time alerts and improved accuracy algorithms in Libre’s relatively smaller form factor,” wrote William Blair’s Margaret Kaczor at the time.

Subsequently, it revealed a host of data at the virtual PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions in June related to Mitraclip, Tendyne and Triclip, as well as other products.

Finally, at the end of June, Abbott and San Diego-based Tandem Diabetes Care Inc. said they had finalized an agreement related to integrated diabetes solutions. The two companies plan to combine Abbott's Freestyle Libre CGM technology with Tandem's insulin delivery systems, with an eye toward providing more options for diabetes management.

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