Abbott Receives FDA Approval for TriClip™, First-of-Its-Kind Device to Repair Leaky Tricuspid Heart Valve

Rhea-AI Summary

Abbott's TriClip receives FDA approval for treating tricuspid regurgitation, offering a safe and minimally invasive option. The approval follows positive trial results showing significant symptom improvement and quality of life benefits. TriClip is designed to repair leaky tricuspid valves, providing an alternative to high-risk open-heart surgery for patients.

Insights

Medical Research Analyst

The FDA approval of Abbott's TriClip system signifies a pivotal development in the management of tricuspid regurgitation (TR), a condition affecting millions in the U.S. alone. The TriClip device, which is based on transcatheter edge-to-edge repair (TEER) technology, offers a significant advancement in treating patients ineligible for surgery. This approval could potentially expand Abbott's market share in the structural heart disease space, a sector that has been growing due to technological advancements and an aging population.

From a medical research perspective, the TRILUMINATE Pivotal trial's results are noteworthy, demonstrating substantial improvements in patient outcomes. These results could lead to increased adoption of the TriClip system, as they suggest a viable alternative to open-heart surgery with a strong safety profile. This is particularly relevant for a patient demographic that is typically older and has a higher surgical risk. The implications for healthcare providers include a shift in treatment protocols and potential cost savings associated with reduced hospital stays and recovery times.

Healthcare Market Analyst

Abbott's TriClip's FDA approval presents an opportunity to capture a niche yet significant portion of the cardiovascular market. The device's approval could stimulate growth in the structural heart segment, which has been increasingly competitive. The TriClip's approval could also encourage further investment in R&D for minimally invasive solutions, potentially leading to a broader range of treatment options for cardiac patients.

Financially, the approval may lead to a positive impact on Abbott's stock as investors anticipate the potential for increased sales and market penetration. The long-term benefits for Abbott include strengthening its position as a leader in structural heart therapies and reinforcing its comprehensive portfolio of cardiovascular products. However, it's important to monitor how the market adoption rate and competition from other minimally invasive cardiac devices could affect Abbott's financial performance in this segment.

Financial Analyst

The FDA's green light for Abbott's TriClip system represents not just a clinical but also a financial milestone. This approval could lead to an uptick in revenue for Abbott, as it taps into a patient population that previously had limited treatment options. The sustained benefits observed at one year post-procedure in the TRILUMINATE Pivotal trial suggest that the TriClip could become a standard of care for TR, which would translate into a steady demand for the product.

Investors should note the potential for increased sales in the U.S. market, which could be reflected in future financial results. However, it's important to consider the costs associated with marketing and production scale-up, as well as the potential for reimbursement challenges or pricing pressures in the healthcare market. In assessing Abbott's stock, one should weigh these factors against the company's track record of successful product launches and its established presence in the structural heart device market.

• TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
• More than 1.6 million people in the U.S. are affected by tricuspid regurgitation,¹ which can severely impact quality of life
• Data from the TRILUMINATE™ Pivotal trial demonstrated that patients who received TriClip experienced a marked improvement in the severity of their symptoms and quality of life, with benefits sustained at one year

ABBOTT PARK, Ill., April 2, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip™ transcatheter edge-to-edge repair (TEER) system that's 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 abstention that the benefits of TriClip outweighed the risks.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9255151-abbott-receives-fda-approval-for-triclip-device-to-repair-leaky-tricuspid-heart-valve/

"The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."

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, TR 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.

As part of its 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. In the study, 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.

"This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions."

TriClip leverages the same clip-based technology as Abbott's leading MitraClip™ device – which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation) – but was specifically designed to treat the tricuspid valve's complex anatomy.

TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR.

Abbott offers the industry's most comprehensive portfolio of structural heart solutions. In addition to TriClip, the company's innovative, minimally invasive therapies include first-of-its-kind technologies MitraClip and Amplatzer Piccolo™ Occluder (to close a hole in the heart of babies), as well as the Navitor™ transcatheter aortic valve implantation system (to treat aortic stenosis). Abbott continues to focus on addressing the unmet needs of patients with structural heart disease and advancing standards of care so people can live their fullest possible lives.

For U.S. important safety information on TriClip, visit https://abbo.tt/TriClip_ISI.

For U.S. important safety information on MitraClip, visit https://abbo.tt/MitraClipISI.

For U.S. important safety information on the Amplatzer Piccolo Occluder, visit https://abbo.tt/PiccoloISI.

For U.S. important safety information on Navitor, visit https://abbo.tt/NavitorISI. 

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. 

1 Kolte, Dhaval & Elmariah, Sammy. (2020). Current state of transcatheter tricuspid valve repair. Cardiovascular Diagnosis and Therapy. 10. 89-97. 10.21037/cdt.2019.09.11.

 

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SOURCE Abbott

FAQ

What is the significance of Abbott's TriClip receiving FDA approval?

Abbott's TriClip has received FDA approval for treating tricuspid regurgitation, offering a safe and minimally invasive treatment option for patients.

How does TriClip work to repair tricuspid valves?

TriClip's TEER technology works by clipping together a portion of the leaflets to repair the tricuspid valve and improve blood flow without open-heart surgery.

What were the results of the TRILUMINATE Pivotal trial for TriClip?

The TRILUMINATE Pivotal trial showed that 90% of patients who received TriClip experienced a marked improvement in their tricuspid regurgitation grade, with a reduction sustained at one year.

How does TriClip compare to Abbott's MitraClip device?

TriClip leverages the same clip-based technology as MitraClip but is specifically designed for treating the tricuspid valve's complex anatomy.

What are the safety and effectiveness findings of TriClip?

TriClip demonstrated a highly favorable safety profile in the TRILUMINATE Pivotal trial, with 98% of patients free of major adverse events through 30 days, along with a significant improvement in quality of life.