Abbott Vascular has just announced the latest results from its EVEREST II trial, which has been evaluating the performance of the company’s MitraClip Mitral Valve Repair System. The study results, published in The New England Journal of Medicine, show that while the MitraClip was slightly less effective than traditional surgery at treating mitral valve regurgitation, treatment with the device resulted in “increased safety, improved left ventricular dimensions, and clinical improvements in NYHA class and quality of life.” The CE marked MitraClip has been available in Europe since 2008, and is currently under FDA review in the US.
From Abbott’s announcement:
The EVEREST II pivotal trial is a multi-center, randomized clinical trial of 279 patients in the United States and Canada with moderate-to-severe (3+) or severe (4+) MR who were candidates for mitral valve surgery.
In addition to the clinical success rate at one and two years, data from the EVEREST II study showed the following on an ITT basis:
• At 30 days, the MitraClip system demonstrated superior safety compared to surgery, with 15.0 percent of MitraClip patients and 47.9 percent of surgery patients experiencing a major adverse event (MAE) (p<0.001). Major adverse events are defined as a composite of 12 pre-specified adverse events. • At one and two years, both the MitraClip and surgery groups experienced a significant reduction (p<0.05) in the end systolic and end diastolic volume of the left ventricle heart chamber compared to baseline, indicating an improvement in heart function. In both groups, the decrease in end diastolic volume that was observed between baseline and one year continued to decrease between years one and two. • Both the MitraClip device and surgery experienced a statistically significant reduction in New York Heart Association (NYHA) Functional Class symptoms at one year that was sustained through two years. NYHA Functional Class provides a scale that assists in the determination of functional ability in patients with heart disease. • At two years, 78 percent of patients randomized to the MitraClip device were free from surgery.
Press release: Data from Landmark Clinical Trial of Abbott’s MitraClip® System Demonstrate Durable Clinical Benefits for Patients with Mitral Regurgitation Two Years After Treatment…
Product Page: MitraClip Mitral Valve Repair System…
Flashbacks: MitraClip Repair Device Showing Positive Results in Study; Study Initiated to Trial Tiny MR Repair Clip; Percutaneous MitraClip System Debuts In Europe; The MitraClip
