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Abbott (ABT) Receives FDA's Approval for the TriClip TEER System
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Abbott Laboratories, Inc. (ABT - Free Report) recently secured the FDA’s approval for the TriClip transcatheter edge-to-edge repair (TEER) system, which is specifically designed for the treatment of tricuspid regurgitation (TR) or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstentions, that the benefits of TriClip outweighed the risks.
The approval helps address a treatment gap for people with TR, who previously had limited options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions. The latest development will also significantly boost the company’s Structural Heart portfolio within the Medical Devices segment.
Significance of TriClip
Abbott’s first-of-its-kind, minimally invasive device has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. TriClip leverages the same clip-based technology as the company’s leading MitraClip device, which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation). However, the device is specifically designed to treat the tricuspid valve's complex anatomy and has already been used to treat more than 10,000 people with TR.
Image Source: Zacks Investment Research
The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, it can lead to atrial fibrillation, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person's quality of life.
Delivered through a vein in the leg, TriClip's TEER technology works by clipping together a portion of the leaflets — or flaps of tissue — to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip only need one day in the hospital before they recover and can return home.
More on the News
The addition of TriClip to Abbott’s broad structural heart therapy offerings in the United States highlights the company’s focus on bringing meaningful, life-enhancing benefits to patients with cardiovascular conditions. As part of the approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery.
The study showed that 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days, a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days and a significant improvement in quality of life.
Industry Prospects
Per a Research report, the global tricuspid valve repair market was valued at 638.1 million in 2022 and is expected to witness a CAGR of 5.9% by 2030.
Progress in the Medical Devices Segment
Last month, Abbott received a CE Mark for its Assert-IQ insertable cardiac monitor, its latest addition to the portfolio of connected health devices. The offering gives physicians a new option for diagnostic evaluation and long-term monitoring of people experiencing abnormal heartbeats.
Furthermore, the company’s diabetes care business received a significant boost from the FreeStyle Libre continuous glucose monitoring systems. Findings from two real-world studies demonstrated that people with Type 2 diabetes using GLP-1 medicines and FreeStyle Libre technology together had greater improvement in their HbA1c (a measurement of a person's average blood glucose level over three months) when compared to those treated with GLP-1 medicines only.
Price Performance
In the past six months, Abbott shares have gained 13.7% compared with the industry’s rise of 15.1%.
DaVita’s stock has surged 63.8% in the past year. Earnings estimates for DaVita have risen from $8.97 to $9.23 in 2024 and from $9.77 to $10.01 in 2025 in the past 30 days.
DVA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it posted an earnings surprise of 22.2%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 20.8% upward in the past year compared with the industry’s rise of 2.7%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.1%. In the last reported quarter, it delivered an average earnings surprise of 5.8%.
Estimates for Cardinal Health’s 2024 earnings per share have moved down 0.1% to $7.28 in the past seven days. Shares of the company have surged 39% in the past year compared with the industry’s 9.2% rise.
CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%. In the last reported quarter, it delivered an average earnings surprise of 16.7%.
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Abbott (ABT) Receives FDA's Approval for the TriClip TEER System
Abbott Laboratories, Inc. (ABT - Free Report) recently secured the FDA’s approval for the TriClip transcatheter edge-to-edge repair (TEER) system, which is specifically designed for the treatment of tricuspid regurgitation (TR) or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstentions, that the benefits of TriClip outweighed the risks.
The approval helps address a treatment gap for people with TR, who previously had limited options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions. The latest development will also significantly boost the company’s Structural Heart portfolio within the Medical Devices segment.
Significance of TriClip
Abbott’s first-of-its-kind, minimally invasive device has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. TriClip leverages the same clip-based technology as the company’s leading MitraClip device, which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation). However, the device is specifically designed to treat the tricuspid valve's complex anatomy and has already been used to treat more than 10,000 people with TR.
Image Source: Zacks Investment Research
The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, it can lead to atrial fibrillation, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person's quality of life.
Delivered through a vein in the leg, TriClip's TEER technology works by clipping together a portion of the leaflets — or flaps of tissue — to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip only need one day in the hospital before they recover and can return home.
More on the News
The addition of TriClip to Abbott’s broad structural heart therapy offerings in the United States highlights the company’s focus on bringing meaningful, life-enhancing benefits to patients with cardiovascular conditions. As part of the approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery.
The study showed that 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days, a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days and a significant improvement in quality of life.
Industry Prospects
Per a Research report, the global tricuspid valve repair market was valued at 638.1 million in 2022 and is expected to witness a CAGR of 5.9% by 2030.
Progress in the Medical Devices Segment
Last month, Abbott received a CE Mark for its Assert-IQ insertable cardiac monitor, its latest addition to the portfolio of connected health devices. The offering gives physicians a new option for diagnostic evaluation and long-term monitoring of people experiencing abnormal heartbeats.
Furthermore, the company’s diabetes care business received a significant boost from the FreeStyle Libre continuous glucose monitoring systems. Findings from two real-world studies demonstrated that people with Type 2 diabetes using GLP-1 medicines and FreeStyle Libre technology together had greater improvement in their HbA1c (a measurement of a person's average blood glucose level over three months) when compared to those treated with GLP-1 medicines only.
Price Performance
In the past six months, Abbott shares have gained 13.7% compared with the industry’s rise of 15.1%.
Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita (DVA - Free Report) , Stryker (SYK - Free Report) and Cardinal Health (CAH - Free Report) . While DaVita sports a Zacks Rank #1 (Strong Buy), Stryker and Cardinal Health carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s stock has surged 63.8% in the past year. Earnings estimates for DaVita have risen from $8.97 to $9.23 in 2024 and from $9.77 to $10.01 in 2025 in the past 30 days.
DVA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it posted an earnings surprise of 22.2%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 20.8% upward in the past year compared with the industry’s rise of 2.7%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.1%. In the last reported quarter, it delivered an average earnings surprise of 5.8%.
Estimates for Cardinal Health’s 2024 earnings per share have moved down 0.1% to $7.28 in the past seven days. Shares of the company have surged 39% in the past year compared with the industry’s 9.2% rise.
CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%. In the last reported quarter, it delivered an average earnings surprise of 16.7%.