ABBOTT PARK, Ill. - The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) for Abbott’s Coronary Intravascular Lithotripsy (IVL) System, a new technology aimed at treating severe arterial calcification in patients with Coronary Artery Disease (CAD). Abbott (NYSE: ABT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $219 billion, continues to demonstrate its innovation leadership. According to InvestingPro analysis, the company maintains a strong financial health score of GOOD, supporting its ongoing investment in breakthrough technologies. The approval, announced today, allows the commencement of the TECTONIC clinical trial, which will assess the system’s efficacy in vessel preparation before stent placement.
Coronary Artery Disease is the leading cause of death in the United States, affecting over 20 million adults. Traditional treatments for calcified arterial blockages include methods such as cutting balloons and atherectomy technology. Abbott’s Coronary IVL System, however, utilizes high-energy sound pressure waves to fracture arterial calcium, which may lead to improved vessel expansion and stent deployment.
The TECTONIC trial will enroll up to 335 participants across 47 U.S. sites to evaluate this potential new treatment option. Dr. Eric Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston, MA, and co-principal investigator of the trial, emphasized the challenges presented by severe calcification in CAD treatment and the importance of optimizing stent placement. With annual revenue of $42 billion and a robust R&D pipeline, Abbott continues to strengthen its market position. InvestingPro subscribers can access detailed analysis of Abbott’s financial performance, including 10+ additional ProTips and comprehensive valuation metrics.
Abbott’s Coronary IVL System is part of the company’s comprehensive vascular portfolio, which includes technologies like optical coherence tomography (OCT) imaging to detect calcium buildup. These advancements aim to enhance the safety and effectiveness of interventions for CAD patients.
Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott’s vascular business, stated that the company, recognized for its contributions to treating coronary artery disease, is committed to improving diagnostics and therapeutic options. The evaluation of the Coronary IVL System is a step toward advancing their portfolio of treatments.
The Coronary IVL system by Abbott remains an investigational device and is not yet available commercially. This news is based on a press release statement from Abbott. The company’s strong financial foundation, evidenced by its 55-year history of consistent dividend payments and low price volatility, positions it well for continued innovation in the healthcare sector. For comprehensive analysis and detailed financial metrics, investors can access Abbott’s full Pro Research Report, available exclusively on InvestingPro.
In other recent news, Abbott Laboratories has been at the center of several significant developments. The company is facing legal challenges as a retrial was ordered in the Whitfield infant formula case, originally decided in Abbott’s favor. This legal situation has drawn attention from analysts, with BofA Securities maintaining a Buy rating and a $150 price target, while Citi analyst Joanna Wuensch also retained a Buy rating with a $160 target, noting the potential impact of ongoing litigation. The legal proceedings could extend over the next few years, with Abbott preparing for a federal multidistrict litigation scheduled for May 2025.
Meanwhile, Abbott has partnered with Cadrenal Therapeutics for a clinical trial focused on tecarfarin, a drug intended for patients with left ventricular assist devices (LVADs). This collaboration aims to leverage Abbott’s experience with HeartMate 3™ LVAD trials to enhance trial design and patient enrollment. Additionally, Abbott’s strong fundamentals have been highlighted by analysts, with expectations of double-digit earnings per share growth and durable revenue growth. Despite the legal challenges, analysts suggest Abbott’s defensive nature may be advantageous in the current economic climate. These recent developments have kept investors closely monitoring Abbott Laboratories’ activities.
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