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Abbott (ABT) Receives FDA Nod for Amplatzer Amulet Device
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Abbott Laboratories (ABT - Free Report) recently received the FDA go-ahead for its Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The Amulet initially received CE Mark in 2013, following which it has been approved for use in more than 80 countries. The recent FDA authorization is backed by findings from the Amulet IDE trial, which compares the Amulet with an alternative minimally-invasive LAA occlusion device.
Abbott's Amulet reduces the risk of stroke in AFib patients as it offers immediate occlusion (or closure) of the left atrial appendage (LAA) during minimally-invasive procedures and thereby eliminates the need for blood-thinning medication. This device is beneficial for patients who are unable to take blood-thinning medication long term. It also provides physicians with a treatment option that does not involve the bleeding risks associated with blood-thinning medicines.
The recent FDA authorization for Abbott’s Amulet is expected to expand the company’s structural heart business within the Medical Device arm.
More in the News
Abbott's Amulet utilizes a dual-seal technology to seal off the LAA entirely and immediately without the need for blood-thinning medication following the procedure. The device is capable of treating a broad range of anatomies and features the widest range of occluder sizes in the market. Further, it is recapturable and repositionable to ensure optimal placement.
Image Source: Zacks Investment Research
Prior to the approval, the only minimally-invasive option for LAA occlusion available in the United States is a solution with a single component to seal the LAA that requires blood-thinning medication and additional patient monitoring. Per management, the FDA approval for Amulet is an important milestone for the company that enables it to reach this treatment option to American physicians and patients.
Industry Prospects
Per a report published in Persistence Market Research, the global atrial fibrillation devices market is expected to see a CAGR of 14% during 2020-2030. Factors such as growing incidence of Afib amongst the geriatric and adult population, rising adoption of minimally-invasive techniques as a treatment for Afib, technological advancements and favorable reimbursement scenario are expected to fuel market growth during the forecast period.
Given the substantial market prospects, the recent FDA authorization for Abbott’s Amulet device seems well-timed.
Notable Developments
In August 2021, Abbott received FDA authorization for its latest optical coherence tomography (OCT) imaging platform, powered by the company's new Ultreon Software. The Ultreon Software is the first-of-its-kind imaging software that combines OCT with artificial intelligence to offer physicians an enhanced and comprehensive view of coronary blood flow and blockages to assist in physicians’ decision-making and provide the best treatment course for patients.
In the same month, the company announced the receipt of FDA approval for its FreeStyle Libre 2 iOS application, compatible for use with iPhones. This application provides a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous glucose monitoring system. It enables users to receive glucose readings directly on their iPhones and to share their glucose data with their caregivers through the LibreLinkUp application.
In July 2021, Abbott launched Jot Dx, its latest insertable cardiac monitor (ICM), in the United States. The Jot Dx enables clinicians and hospitals to control the amount of electronic data received for irregular heart rhythms. It permits remote detection and improved diagnosis accuracy of cardiac arrythmia in patients. The Jot Dx ICM is supported by Abbott’s personalized concierge service, SyncUP.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 24.5% compared with the industry’s 10.5% growth.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the Medical-Products industry include VAREX IMAGING (VREX - Free Report) , Envista Holdings Corporation (NVST - Free Report) and BellRing Brands, Inc. (BRBR - Free Report) .
Image: Shutterstock
Abbott (ABT) Receives FDA Nod for Amplatzer Amulet Device
Abbott Laboratories (ABT - Free Report) recently received the FDA go-ahead for its Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The Amulet initially received CE Mark in 2013, following which it has been approved for use in more than 80 countries. The recent FDA authorization is backed by findings from the Amulet IDE trial, which compares the Amulet with an alternative minimally-invasive LAA occlusion device.
Abbott's Amulet reduces the risk of stroke in AFib patients as it offers immediate occlusion (or closure) of the left atrial appendage (LAA) during minimally-invasive procedures and thereby eliminates the need for blood-thinning medication. This device is beneficial for patients who are unable to take blood-thinning medication long term. It also provides physicians with a treatment option that does not involve the bleeding risks associated with blood-thinning medicines.
The recent FDA authorization for Abbott’s Amulet is expected to expand the company’s structural heart business within the Medical Device arm.
More in the News
Abbott's Amulet utilizes a dual-seal technology to seal off the LAA entirely and immediately without the need for blood-thinning medication following the procedure. The device is capable of treating a broad range of anatomies and features the widest range of occluder sizes in the market. Further, it is recapturable and repositionable to ensure optimal placement.
Image Source: Zacks Investment Research
Prior to the approval, the only minimally-invasive option for LAA occlusion available in the United States is a solution with a single component to seal the LAA that requires blood-thinning medication and additional patient monitoring. Per management, the FDA approval for Amulet is an important milestone for the company that enables it to reach this treatment option to American physicians and patients.
Industry Prospects
Per a report published in Persistence Market Research, the global atrial fibrillation devices market is expected to see a CAGR of 14% during 2020-2030. Factors such as growing incidence of Afib amongst the geriatric and adult population, rising adoption of minimally-invasive techniques as a treatment for Afib, technological advancements and favorable reimbursement scenario are expected to fuel market growth during the forecast period.
Given the substantial market prospects, the recent FDA authorization for Abbott’s Amulet device seems well-timed.
Notable Developments
In August 2021, Abbott received FDA authorization for its latest optical coherence tomography (OCT) imaging platform, powered by the company's new Ultreon Software. The Ultreon Software is the first-of-its-kind imaging software that combines OCT with artificial intelligence to offer physicians an enhanced and comprehensive view of coronary blood flow and blockages to assist in physicians’ decision-making and provide the best treatment course for patients.
In the same month, the company announced the receipt of FDA approval for its FreeStyle Libre 2 iOS application, compatible for use with iPhones. This application provides a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous glucose monitoring system. It enables users to receive glucose readings directly on their iPhones and to share their glucose data with their caregivers through the LibreLinkUp application.
In July 2021, Abbott launched Jot Dx, its latest insertable cardiac monitor (ICM), in the United States. The Jot Dx enables clinicians and hospitals to control the amount of electronic data received for irregular heart rhythms. It permits remote detection and improved diagnosis accuracy of cardiac arrythmia in patients. The Jot Dx ICM is supported by Abbott’s personalized concierge service, SyncUP.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 24.5% compared with the industry’s 10.5% growth.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the Medical-Products industry include VAREX IMAGING (VREX - Free Report) , Envista Holdings Corporation (NVST - Free Report) and BellRing Brands, Inc. (BRBR - Free Report) .
VAREX, sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Envista Holdings, with a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.8%.
BellRing Brands, carrying a Zacks Rank #2, has a long-term earnings growth rate of 25.3%.