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ABT Stock to Gain From FDA IDE Approval for Its Coronary IVL System
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Abbott (ABT - Free Report) has received the FDA’s investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (“IVL”) system to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC Coronary Artery Disease (“CAD”) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the United States.
The company’s investigational Coronary IVL technology builds upon its existing vascular portfolio, part of the Medical Devices segment, and is designed to address the challenges of currently available IVL systems.
ABT Stock’s Likely Trend Following the News
After the announcement yesterday, Abbott shares edged up 0.7%, finishing at $127.21. The company presently offers a range of treatment solutions, including optical coherence tomography (OCT) imaging technology, which assesses coronary arteries and detects calcium buildup to help physicians identify the arteries that could benefit from plaque modification. Abbott’s advanced technologies are designed to ensure complete vascular support, including artery assessment, preparation and treatment. We expect the market sentiment toward ABT stock to remain positive surrounding this development.
Abbott holds a market capitalization of $219.11 billion. The company’s earnings yield of 4.1% surpasses the industry average yield of 0.3%. The company delivered an average earnings beat of 1.6% in the trailing four quarters.
Relevance of Abbott’s New IVL System
With more than 20 million adults impacted, CAD remains the most common heart disease in the United States. The condition develops when plaque builds up in the vessel, blocking blood flow and oxygen supply to the heart, requiring vessel interventions. Physicians often use several therapy approaches to clear calcified arterial blockages, including cutting balloons and atherectomy technology. IVL is a newer treatment for calcified coronary arteries that treats blockages by fracturing the calcium within the artery wall, potentially allowing for vessel expansion and better stent placement. Abbott's investigational Coronary IVL System leverages high-energy sound pressure waves to treat calcium blockages before placing a stent.
Image Source: Zacks Investment Research
Abbott plays a key role in CAD treatment, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. By partnering with physicians to evaluate its Coronary IVL System, the company is exploring the next generation of calcium modification technology and expanding the treatment options.
Industry Prospects Favoring ABT
Per a Research report, the global CAD market was valued at $22.07 billion in 2024 and is set to witness a compound annual rate of 8.9% through 2031. The rising CAD prevalence around the world fuels the market’s growth, along with higher funding for research and development of therapies and an increase in comorbid conditions, including atherosclerosis and hypertension.
Other Developments in Abbott’s Medical Devices Arm
In December 2024, Abbott completed the world's first-in-human leadless left bundle branch area pacing procedures using the investigational AVEIR Conduction System Pacing leadless pacemaker system as part of a feasibility study. These procedures mark the first time a leadless pacemaker has been implanted into the left bundle branch area, offering people with slower-than-normal heart rhythms a new potential treatment option.
ABT Stock Price Performance
In the past six months, Abbott shares have risen 10.4%, surpassing the industry’s 3.8% growth.
Estimates for Hims & Hers Health’s 2025 earnings per share have jumped 21.2% to 63 cents in the past 30 days. Shares of the company have surged 136.5% in the past year against the industry’s 12.2% fall. Its earnings yield of 1.8% also outpaced the industry’s -4.6% yield. HIMS’ earnings surpassed estimates in two of the trailing four quarters, matched in one and missed on another occasion, the average surprise being 40.4%.
Boston Scientific shares have rallied 51.1% in the past year. Estimates for the company’s 2025 earnings per share have remained constant at $2.85 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.3%. In the last reported quarter, it posted an earnings surprise of 7.7%.
Estimates for Cardinal Health’s fiscal 2025 earnings per share have increased 1 cent to $7.94 in the past 30 days. Shares of the company have jumped 19.4% in the past year against the industry’s 3.5% fall. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
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ABT Stock to Gain From FDA IDE Approval for Its Coronary IVL System
Abbott (ABT - Free Report) has received the FDA’s investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (“IVL”) system to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC Coronary Artery Disease (“CAD”) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the United States.
The company’s investigational Coronary IVL technology builds upon its existing vascular portfolio, part of the Medical Devices segment, and is designed to address the challenges of currently available IVL systems.
ABT Stock’s Likely Trend Following the News
After the announcement yesterday, Abbott shares edged up 0.7%, finishing at $127.21. The company presently offers a range of treatment solutions, including optical coherence tomography (OCT) imaging technology, which assesses coronary arteries and detects calcium buildup to help physicians identify the arteries that could benefit from plaque modification. Abbott’s advanced technologies are designed to ensure complete vascular support, including artery assessment, preparation and treatment. We expect the market sentiment toward ABT stock to remain positive surrounding this development.
Abbott holds a market capitalization of $219.11 billion. The company’s earnings yield of 4.1% surpasses the industry average yield of 0.3%. The company delivered an average earnings beat of 1.6% in the trailing four quarters.
Relevance of Abbott’s New IVL System
With more than 20 million adults impacted, CAD remains the most common heart disease in the United States. The condition develops when plaque builds up in the vessel, blocking blood flow and oxygen supply to the heart, requiring vessel interventions. Physicians often use several therapy approaches to clear calcified arterial blockages, including cutting balloons and atherectomy technology. IVL is a newer treatment for calcified coronary arteries that treats blockages by fracturing the calcium within the artery wall, potentially allowing for vessel expansion and better stent placement. Abbott's investigational Coronary IVL System leverages high-energy sound pressure waves to treat calcium blockages before placing a stent.
Image Source: Zacks Investment Research
Abbott plays a key role in CAD treatment, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. By partnering with physicians to evaluate its Coronary IVL System, the company is exploring the next generation of calcium modification technology and expanding the treatment options.
Industry Prospects Favoring ABT
Per a Research report, the global CAD market was valued at $22.07 billion in 2024 and is set to witness a compound annual rate of 8.9% through 2031. The rising CAD prevalence around the world fuels the market’s growth, along with higher funding for research and development of therapies and an increase in comorbid conditions, including atherosclerosis and hypertension.
Other Developments in Abbott’s Medical Devices Arm
In December 2024, Abbott completed the world's first-in-human leadless left bundle branch area pacing procedures using the investigational AVEIR Conduction System Pacing leadless pacemaker system as part of a feasibility study. These procedures mark the first time a leadless pacemaker has been implanted into the left bundle branch area, offering people with slower-than-normal heart rhythms a new potential treatment option.
ABT Stock Price Performance
In the past six months, Abbott shares have risen 10.4%, surpassing the industry’s 3.8% growth.
ABT’s Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space include Hims & Hers Health (HIMS - Free Report) , Boston Scientific (BSX - Free Report) and Cardinal Health (CAH - Free Report) . Each of these carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Hims & Hers Health’s 2025 earnings per share have jumped 21.2% to 63 cents in the past 30 days. Shares of the company have surged 136.5% in the past year against the industry’s 12.2% fall. Its earnings yield of 1.8% also outpaced the industry’s -4.6% yield. HIMS’ earnings surpassed estimates in two of the trailing four quarters, matched in one and missed on another occasion, the average surprise being 40.4%.
Boston Scientific shares have rallied 51.1% in the past year. Estimates for the company’s 2025 earnings per share have remained constant at $2.85 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.3%. In the last reported quarter, it posted an earnings surprise of 7.7%.
Estimates for Cardinal Health’s fiscal 2025 earnings per share have increased 1 cent to $7.94 in the past 30 days. Shares of the company have jumped 19.4% in the past year against the industry’s 3.5% fall. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.