FDA Advisory Committee Votes in Favor of Abbott's First-of-Its-Kind TriClip™ System to Treat People With a Leaky Tricuspid Heart Valve
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Insights
The TriClip system's potential impact on the treatment of tricuspid regurgitation (TR) is significant, considering the limited options currently available for patients who are ineligible for surgery. The panel's favorable vote on the safety and effectiveness of the TriClip system reflects a promising advancement in cardiology, especially for a condition that can lead to severe complications such as heart failure, arrhythmias and organ dysfunction. The TEER technology employed by TriClip is a minimally invasive approach, which could lead to a paradigm shift in how TR is managed, potentially reducing hospital stays and recovery times compared to traditional surgery. This is particularly relevant for elderly or frail patients who are often at higher risk during open-heart procedures.
From an industry perspective, the adoption of the TriClip system in over 50 countries and its use in treating over 10,000 patients highlights its global market penetration and the demand for minimally invasive structural heart devices. The FDA's impending decision, expected in 2024, could open a substantial market opportunity for Abbott within the United States. Given the prevalence of TR and the aging population, the market potential for the TriClip system is considerable. Additionally, Abbott's comprehensive portfolio in structural heart solutions, including MitraClip and Navitor, positions the company as a leader in this space, potentially affecting its market share and investor sentiment. The financial implications for Abbott will depend on the FDA's final decision, reimbursement policies and the system's adoption by healthcare providers.
The economic implications of introducing a device like TriClip are multifaceted. On one hand, the system could lead to cost savings by reducing the need for more invasive surgeries and the associated costs of prolonged hospitalization and postoperative care. This aligns with the broader healthcare trend towards cost-effective treatments that can be delivered in less resource-intensive settings. On the other hand, the initial costs of the device and the training required for its deployment could be substantial. However, if the long-term benefits result in fewer hospital readmissions and improved patient outcomes, the TriClip system could be seen as a cost-effective intervention for managing TR, influencing healthcare policy and insurance coverage decisions.
- Panel of independent experts reviewed data from the TRILUMINATE™ pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system
- An investigational device in the U.S., TriClip is approved in more than 50 countries and has treated more than 10,000 people with tricuspid regurgitation worldwide
ABBOTT PARK, Ill., Feb. 13, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the
"Tricuspid regurgitation can put added strain on the heart and lead to other cardiovascular issues, which can significantly worsen a person's quality of life, but historically there have been few treatment options," said Lars Søndergaard, M.D., chief medical officer and divisional vice president of medical affairs of Abbott's structural heart business. "Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery."
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. 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 a potentially new 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.
After reviewing data from Abbott's TRILUMINATE pivotal trial and listening to testimony, the panel voted on the device's safety, effectiveness and risk/benefit profile as a treatment for TR. On the question of whether there is enough data to support the safety of the device, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor. On the final question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor.
"Tricuspid regurgitation can cause fatigue, shortness of breath, irregular heart rhythms, swelling and organ dysfunction. As the disease progresses, it is often debilitating and impacts a person's ability to live the life they want," said David Adams, M.D., chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, who served as co-principal investigator of the TRILUMINATE pivotal trial. "In the TRILUMINATE pivotal trial, we found that
Abbott submitted its pre-market approval (PMA) application for the TriClip device in March 2023 to the FDA, which lead to today's advisory committee panel for expert advice on the device's clinical safety, effectiveness, risk and benefit. The FDA routinely seeks input from advisory committees, especially for first-of-a-kind medical devices. The FDA's decision on Abbott's TriClip is expected in 2024.
TriClip is approved for use in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with TR. It is an investigational device in
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™ (to treat leaky valves in people with mitral regurgitation) 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.
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About the Abbott TRILUMINATE Pivotal Trial
The TRILUMINATE pivotal trial is the world's first randomized, controlled clinical trial evaluating the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy in people with symptomatic severe TR who are at intermediate or greater risk for open-heart surgery. Data presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in October 2023 for all randomized patients (N=572) and those enrolled in the concurrent single-arm group (patients with more complex tricuspid valve anatomy) illustrated the device's safety, effectiveness and benefits.
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.
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