The FDA reviewers concluded that the device could not be approved, citing multiple problems with the registry data, which were not intended to be used as pivotal data, were difficult to interpret, and could only be considered "hypothesis-generating" at this point.
Abbott recently started two studies – one in the United States involving patients with symptomatic functional mitral regurgitation who are not good surgical candidates, the other a postmarketing study in Europe of patients with severe heart failure – and has plans for postmarketing studies in the United States, including 5-year follow-up of the patients in the combined high-risk registry trials, and a national MitraClip patient registry.
The device received the equivalent of approval in the European Union in 2008 and is marketed in about 30 countries, according to Abbott.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, and at this meeting, two such waivers were granted to the panel chair, Dr. Jeffrey Borer, professor of medicine at the State University of New York, Downstate Medical Center in Brooklyn, and Dr. Vetrovec. Dr. Borer also is an adjunct professor at Cornell University, a clinical site of a MitraClip study, but he is not one of the investigators. Dr. Vetrovec reported stockholdings in Abbott and in two firms that make competing products.