ABT Stock to Gain From FDA IDE Approval for Its Coronary IVL System

Abbott ABT 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 NewsAfter 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 SystemWith 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 ResearchAbbott 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 ABTPer 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 ArmIn 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 PerformanceIn the past six months, Abbott shares have risen 10.4%, surpassing the industry’s 3.8% growth.ABT’s Zacks Rank and Key PicksAbbott currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the broader medical space include Hims & Hers Health HIMS, Boston Scientific BSX and Cardinal Health CAH. 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%.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT): Free Stock Analysis Report Boston Scientific Corporation (BSX): Free Stock Analysis Report Cardinal Health, Inc. (CAH): Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks