3/14/2010-Researchers said on Sunday that MitraClip from Abbott Laboratories (NYSE:ABT), proved to be far safer and nearly as effective as open heart surgery in the treatment of mitral regurgitation, meeting the primary goals of a pivotal study.
The company is hoping to use the data to win U.S. approval for MitraClip, which has been available in Europe for about 18 months.
Among patients who received the MitraClip, 9.6% suffered major adverse events compared with 57% in the surgery group, a highly statistically significant difference.
Effectiveness was measured by the lack of need for surgery for valve dysfunction at one year.
The device attained the effectiveness goal in 72.4% of patients compared with 87.8% among surgery patients -- falling within pre-specified parameters of non-inferiority, researchers said.
Dr. Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem and co-principal investigator of the trial, remarked, "This is a stunning difference in safety for an acceptable trade-off in efficacy for many patients."