Abbott has announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip® System for the treatment of mitral regurgitation (MR).
Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco.
Abbott's MitraClip system, an investigational device in the United States, received CE Mark in 2008 and is commercially available in approximately 30 countries, with more than 8,000 patients treated to date.
The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood.
The EVEREST II High Surgical Risk cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies.
Findings from 351 symptomatic U.S. patients deemed too high risk for open mitral valve surgery demonstrated:
• A 30-day mortality rate significantly lower than expected for surgery (4.8 percent for patients treated with the MitraClip system versus 18.2 percent predicted surgical mortality, p<0.0001);
• A low rate of adverse events, despite the high surgical risk profile of the patients
• An implant success rate of 96 percent;
• Acute reduction in MR to 2+ or less achieved in 86 percent of patients treated with the MitraClip device;
• Clinically significant improvement in left ventricular size, significant improvements in NYHA Functional Class and SF-36 Quality of Life scores, and significantly reduced rates of hospitalization for heart failure (48 percent reduction from one year post-discharge compared to the year prior to treatment, p<0.0001).
"Patients with mitral regurgitation who are not candidates for mitral valve surgery due to risk of mortality have an unmet need for a treatment option that will reduce symptoms and improve the quality of their lives," said D. Scott Lim, M.D., associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, Va.
Lim continued, "The findings of the EVEREST II High Surgical Risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalizations for heart failure."
"These results add to the large and growing body of data that show that the first-in-class percutaneous MitraClip therapy can have positive results for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.
Simonton continued, "We look forward to the March 20 FDA Advisory Committee meeting to discuss the MitraClip system as a treatment option for this patient group in the United States."