ABBOTT PARK, Ill. - Abbott has received U.S. Food and Drug Administration (FDA) approval for its TriClip transcatheter edge-to-edge repair (TEER) system, a new device designed to treat tricuspid regurgitation (TR), a condition affecting over 1.6 million Americans. The approval, announced today, follows a favorable vote by the FDA's Circulatory System Devices Panel, which found the benefits of TriClip to outweigh the risks.
Tricuspid regurgitation occurs when the heart's tricuspid valve fails to close properly, causing blood to flow backward and leading to symptoms like fatigue and shortness of breath. If untreated, TR can result in serious health issues, including heart failure. The TriClip system offers a minimally invasive option for patients who are not candidates for surgery, typically due to age or illness.
The device is delivered via a vein in the leg and clips together parts of the valve's leaflets to improve blood flow direction, potentially allowing patients to leave the hospital within a day post-procedure. Data from the TRILUMINATE Pivotal trial demonstrated that 90% of patients treated with TriClip showed significant improvement in their TR grade at 30 days, a benefit sustained after one year. Safety profiles were also favorable, with 98% of patients free of major adverse events through 30 days.
Dr. Paul Sorajja, a co-principal investigator of the TRILUMINATE Pivotal trial, emphasized the importance of TriClip's approval for those suffering from TR, highlighting its ability to restore valve function and improve quality of life without high-risk surgery.
Abbott's structural heart business senior vice president, Sandra Lesenfants, remarked on the significance of filling a treatment gap for TR patients, noting that TriClip complements Abbott's extensive portfolio of structural heart therapies.
TriClip, which builds on the technology of Abbott's MitraClip device for mitral regurgitation, has been approved in over 50 countries and used to treat more than 10,000 people with TR since its initial CE Mark approval in 2020.
The information in this article is based on a press release statement from Abbott.
InvestingPro Insights
As Abbott secures FDA approval for its innovative TriClip system, the company's financial health and market performance provide a complementary backdrop to its clinical advancements. Abbott Laboratories (NYSE: NYSE:ABT) stands with a robust market capitalization of $194.5 billion, reflecting investor confidence and the scale of its operations in the healthcare equipment and supplies industry. The company's commitment to shareholder returns is evident with a history of dividend growth, having increased its dividend for 10 consecutive years and maintained payments for an impressive 54 years.
InvestingPro data further reveals that Abbott is trading at a high earnings multiple with a price-to-earnings (P/E) ratio of 34.21, which adjusts to 32.91 for the last twelve months as of Q4 2023. This indicates that investors may expect high earnings growth in the future, aligning with the company's innovative product releases like the TriClip. Additionally, Abbott's stock is characterized by low price volatility, which might appeal to investors seeking stable investment options in the volatile healthcare sector.
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