Abbott’s MitraClipTM is the world’s first transcatheter mitral valve repair (TMVr) therapy that provides select people living with primary and secondary mitral regurgitation (MR) with a viable treatment option.
Abbott’s MitraClipTM is the world’s first transcatheter mitral valve repair (TMVr) therapy that provides select people living with primary and secondary mitral regurgitation (MR) with a viable treatment option. The MitraClip system is the first-of-its-kind and only transcatheter mitral valve therapy with more than 16 years of clinical experience and proven safety, survival, and durable clinical outcomes.
The device is a small metal clip covered with a polyester fabric that is implanted on your mitral valve proven to repair primary and secondary MR without the need for open-heart surgery. The nonsurgical, minimally invasive device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The treatment works by clipping together portions of the leaflets, or flaps, of the mitral valve to reduce MR, which allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality-of-life. The device and its delivery system are in its fourth-generation of innovation, allowing for precise placement during deployment, resulting in more predictable procedures.
MitraClip is approved in 75 counties worldwide, spanning regions in Asia, Africa, the Americas, and Australia.
COAPT Trial
The landmark Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT™ ) trial investigated MitraClip for the treatment of secondary MR. The study unequivocally showed that patients who received the MitraClip device not only lived longer but were hospitalized less frequently for heart failure and had a better quality-of-life compared to patients who received only medical therapy.
Three-year data from the COAPT trial using MitraClip in patients with heart failure and severe MR found that, over a longer-term follow-up period, transcatheter mitral leaflet approximation with MitraClip was safe, reduced hospitalization rates and improved survival and quality-of-life, compared to medical therapy alone. The findings demonstrated that MitraClip is the first therapy shown to improve prognosis by reducing secondary MR due to left ventricular dysfunction.
Data from a sub-analysis, published in Circulation (2019), also showed that transcatheter mitral valve repair (TMVr) using the MitraClip device in heart failure patients with secondary MR was cost-effective and projected to increase life-expectancy and quality-of-life improvements at an incremental cost, compared to guideline-directed medical therapy (GDMT) alone. These results may further help inform a coverage review being conducted by the Centers for Medicare & Medicaid Services’ (CMS) for an expanded National Coverage Determination (NCD) designation for MitraClip, with the proposed decision memo expected in May 2020.
EXPAND Study
The multi-center, global EXPAND study was initiated to evaluate real-world clinical outcomes associated with the third-generation MitraClip NTR/XTR Clip Delivery Systems, which has expanded the treatment of MR to a broader range of anatomies in an all-comer population. Data from this study continues to support the safety and efficacy of the next-generation MitraClip device. The EXPAND study enrolled a total of 1041 patients at 60 sites in United States, Europe, and the Middle East.
Clinical outcomes from primary MR patients enrolled in the EXPAND study demonstrated that patients treated with the next-generation MitraClip NTR/XTR System experienced significantly greater MR reduction (compared to older generation systems), low mortality rates as well as improvements in quality of life and functional capacity. These results confirmed the safety and efficacy of the MitraClip NTR/XTR system at reducing MR in a real-world setting. Additional analyses and longer-term follow-up is currently underway for patients enrolled in the EXPAND study.
Post-Approval Study 1 MitraClip Registry
The Society of Thoracic Surgeons (STS)/ACC Transcatheter Valve Therapy (TVT) Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures and emerging treatments for valve disease patients.
The real-world Post-Approval Study 1 MitraClip Registry is based on data extracted from the first 2,000 MitraClip patients consecutively entered into the TVT Registry. According to 30-day and one-year data from the first and largest study of site-reported echocardiographic and clinical (functional and quality-of-life) outcomes for the MitraClip System provided meaningful improvements in coronary function and quality-of-life in primary MR.
REPAIR MR Trial
The first-of-its-kind prospective, randomized, controlled trial, REPAIR MR will continue to evaluate the impact of MitraClip therapy on long-term clinical outcomes in moderate-surgical-risk patients with severe primary MR who are often limited to open-heart surgery, which is the current standard of care. The trial’s design addresses the issue that, despite symptoms or other co-morbidities, elderly patients suffering from primary MR are often undertreated by open-heart mitral valve surgery. The trial is intended to show whether in such patients, MitraClip offers a less-invasive, alternative treatment option, compared to open-heart surgery.
The primary endpoint was determined after careful review of the risks and benefits associated with the device and surgery and is a neutral composite of mortality, survival free of stroke and cardiac hospitalizations (excluding hospitalizations within 30 days) at two years, with a total follow-up at five years. Abbott announced FDA approval for the trial in and seeks to enroll 500 patients at 60 sites in the United States, Canada, and Europe to evaluate MitraClip’s effectiveness in this patient population.
Abbott creates life-changing technologies to help people with serious heart abnormalities, such as damaged heart valves or other heart defects, live more fully at all stages of life. As a global healthcare leader that helps people live more fully at all stages of life, we have the most comprehensive structural heart portfolio in the industry. Through its cardiac devices and research, Abbott is addressing the critical unmet needs of people by providing life-saving therapies and offer a renewed chance at life.
