New data reinforce the safety and effectiveness of MitraClip for treating mitral regurgitation

Data include findings that reinforce the value of MitraClip, the world's first and leading transcatheter edge-to-edge repair (TEER) device, to treat leaky valves in people with mitral regurgitation (MR). The new data around Abbott's structural heart therapies were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in Boston (September 16-19, 2022). Results were also presented on TriClip, the first therapy designed specifically for tricuspid heart valve repair; the Amplatzer Amulet Left Atrial Appendage Occluder, a minimally invasive option offering the most complete closure of the left atrial appendage (LAA) to reduce risk of stroke; and Portico, a self-expanding transcatheter aortic valve implantation (TAVI) system.

Structural heart diseases such as valve disease or openings in the heart that require closure can impair how the heart moves blood through the body. New minimally invasive technology has changed how physicians approach patient care and limits the need for more complex or risky surgery.

MitraClip EXPAND G4 Post-Approval Study: Data presented from the prospective, multi-center, global real-world EXPAND G4 study support the safety and effectiveness of the MitraClip G4 system for treating MR. The study represents the largest report of 30-day core lab-assessed outcomes, which included more than 1,000 patients. The data confirm that MitraClip offers high success rates in terms of MR reduction, improvements in quality of life and low adverse event rates. Key findings through 30 days include: i. Significant MR reduction to mild or less (less than grade 1+ on a four-point scale) is achieved in 91% of patients, with lowest reported adverse event rates to date (1.3% all-cause mortality at 30 days). ii. Clinical improvements including 83% of patients achieving New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease, with Class I/II meaning slight or no limitation of physical activity), an improvement of 52% from baseline of 31%; and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life), a 35% improvement from baseline score. iii. Multiple clip sizes enable tailoring the therapy to patients' mitral valve anatomy and expand the spectrum of TEER-suitable patients

"MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation, provides a valuable therapy option that does not require open-heart surgery, and goes beyond simply managing symptoms with medications," said Jason Rogers, M.D., professor of cardiovascular medicine and director of interventional cardiology and structural heart training programs at the University of California, Davis Medical Center. "These late-breaking data demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces MR in a broad range of patients, while restoring proper function of the mitral valve and improving patients' quality of life."

The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 150,000 patients treated worldwide, MitraClip is approved in more than 75 countries, spanning regions in Asia, Africa, Europe, the Americas and Australia.