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Abbott (ABT) Gets FDA Approval for Aspirin-Free HeartMate 3 Regimen
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Abbott Laboratories, Inc. (ABT - Free Report) recently announced that the FDA has approved a change of label for its HeartMate 3 left ventricular assist device (LVAD or heart pump). The development, meant exclusively for patients with an Abbott HeartMate 3 heart pump, aims to provide superior clinical outcomes by eliminating aspirin as part of routine patient management.
The labeling update is backed by the data from the company’s ARIES-HM3 trial and has also been approved by regulatory agencies in Canada and the European Union. This is also likely to boost Abbott’s heart failure business, part of its Medical Devices segment.
Importance of the ARIES-HM3 Trial
Blood thinners have historically been used by patients receiving LVADs as a means to reduce the risk of blood clots associated with the use of a blood pump implant. The ARIES-HM3 trial was an international, randomized study designed to help clinicians understand whether aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients. The implantable device pumps blood through the body in people whose hearts are too weak to do so on their own.
The trial demonstrated that patients who received an Abbott HeartMate 3 heart pump but did not take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot. This is in contrast to patients who also received a HeartMate 3 but did take aspirin. As a result of reduced bleeding risk, the ARIES-HM3 trial also found patients avoiding aspirin post implant experienced reduced days in the hospital compared to patients who took aspirin daily.
Image Source: Zacks Investment Research
Abbott's HeartMate 3 is the only commercially approved heart pump with Full MagLev technology, which allows the device's rotor to be "suspended" by magnetic forces. The unique design has been proven to reduce trauma to blood passing through the pump, improving patient survival and quality of life. These factors have led to HeartMate 3 offering the lowest rate of pump-related complications of any other blood pump.
More on the News
Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness and swollen ankles. If not managed and treated, it can lead to poor quality of life, hospitalizations and death. The company cites data pointing out that nearly 6.7 million Americans have heart failure, and the number is expected to rise to 8.5 million by 2030.
According to the vice president at Abbott's heart failure business, removing aspirin from the HeartMate 3 medication regimen is a simple change that allows people with an Abbott LVAD to focus on the things they love and spend less time worrying about and tending to bleeding events. Research such as the ARIES-HM3 trial is helping the company manage patients with advanced heart failure, aiming to bring life-enhancing benefits to people who rely on its devices to survive.
Industry Prospects
Per a Global Market Insights report, the global heart pump device market was valued at $2.2 billion in 2023 and is expected to witness a CAGR of 17.4% by 2032. The market growth is fueled by factors such as the increase in the number of heart failures and cardiovascular diseases, rising awareness regarding heart failure treatment and the growing R&D expenditure.
Other Developments in the Medical Devices Segment
In June 2024, Abbott’s Diabetes Care business formed a global partnership with Medtronic on an integrated continuous glucose monitoring (CGM) system based on Abbott's FreeStyle Libre technology. The integration of Abbott's CGM sensor with Medtronic's automated insulin delivery (AID) algorithms will enable automatic adjustments of insulin to keep glucose in range. The CGM sensor, designed to work exclusively with Medtronic devices, will be developed by Abbott and sold by Medtronic.
Price Performance
In the past year, Abbott shares have risen 8% compared with the industry’s growth of 13.4%.
Masimo shares have risen 12% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 57.8% in the past year compared with the industry’s rise of 13.4%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.
Estimates for Quest Diagnostics’ 2024 earnings have moved 0.3% north to $8.88 in the past 30 days. Shares of the company have risen 14.7% in the past year compared with the industry’s 22% growth.
DGX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.3%. In the last reported quarter, it delivered an earnings surprise of 1.7%.
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Abbott (ABT) Gets FDA Approval for Aspirin-Free HeartMate 3 Regimen
Abbott Laboratories, Inc. (ABT - Free Report) recently announced that the FDA has approved a change of label for its HeartMate 3 left ventricular assist device (LVAD or heart pump). The development, meant exclusively for patients with an Abbott HeartMate 3 heart pump, aims to provide superior clinical outcomes by eliminating aspirin as part of routine patient management.
The labeling update is backed by the data from the company’s ARIES-HM3 trial and has also been approved by regulatory agencies in Canada and the European Union. This is also likely to boost Abbott’s heart failure business, part of its Medical Devices segment.
Importance of the ARIES-HM3 Trial
Blood thinners have historically been used by patients receiving LVADs as a means to reduce the risk of blood clots associated with the use of a blood pump implant. The ARIES-HM3 trial was an international, randomized study designed to help clinicians understand whether aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients. The implantable device pumps blood through the body in people whose hearts are too weak to do so on their own.
The trial demonstrated that patients who received an Abbott HeartMate 3 heart pump but did not take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot. This is in contrast to patients who also received a HeartMate 3 but did take aspirin. As a result of reduced bleeding risk, the ARIES-HM3 trial also found patients avoiding aspirin post implant experienced reduced days in the hospital compared to patients who took aspirin daily.
Image Source: Zacks Investment Research
Abbott's HeartMate 3 is the only commercially approved heart pump with Full MagLev technology, which allows the device's rotor to be "suspended" by magnetic forces. The unique design has been proven to reduce trauma to blood passing through the pump, improving patient survival and quality of life. These factors have led to HeartMate 3 offering the lowest rate of pump-related complications of any other blood pump.
More on the News
Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness and swollen ankles. If not managed and treated, it can lead to poor quality of life, hospitalizations and death. The company cites data pointing out that nearly 6.7 million Americans have heart failure, and the number is expected to rise to 8.5 million by 2030.
According to the vice president at Abbott's heart failure business, removing aspirin from the HeartMate 3 medication regimen is a simple change that allows people with an Abbott LVAD to focus on the things they love and spend less time worrying about and tending to bleeding events. Research such as the ARIES-HM3 trial is helping the company manage patients with advanced heart failure, aiming to bring life-enhancing benefits to people who rely on its devices to survive.
Industry Prospects
Per a Global Market Insights report, the global heart pump device market was valued at $2.2 billion in 2023 and is expected to witness a CAGR of 17.4% by 2032. The market growth is fueled by factors such as the increase in the number of heart failures and cardiovascular diseases, rising awareness regarding heart failure treatment and the growing R&D expenditure.
Other Developments in the Medical Devices Segment
In June 2024, Abbott’s Diabetes Care business formed a global partnership with Medtronic on an integrated continuous glucose monitoring (CGM) system based on Abbott's FreeStyle Libre technology. The integration of Abbott's CGM sensor with Medtronic's automated insulin delivery (AID) algorithms will enable automatic adjustments of insulin to keep glucose in range. The CGM sensor, designed to work exclusively with Medtronic devices, will be developed by Abbott and sold by Medtronic.
Price Performance
In the past year, Abbott shares have risen 8% compared with the industry’s growth of 13.4%.
Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Masimo (MASI - Free Report) , Boston Scientific (BSX - Free Report) and Quest Diagnostics (DGX - Free Report) . While Masimo sports a Zacks Rank #1 (Strong Buy) at present, Boston Scientific and Quest Diagnostics each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks Rank #1 stocks here.
Masimo shares have risen 12% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 57.8% in the past year compared with the industry’s rise of 13.4%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.
Estimates for Quest Diagnostics’ 2024 earnings have moved 0.3% north to $8.88 in the past 30 days. Shares of the company have risen 14.7% in the past year compared with the industry’s 22% growth.
DGX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.3%. In the last reported quarter, it delivered an earnings surprise of 1.7%.