The MitraClip has been available in the U.S. since 2013 and Europe since 2008 — but is only indicated as an option for people who don’t have the option of open-heart surgery because they are too high-risk.
Abbott officials suspect that some people avoid open-heart surgery to repair a faulty mitral valve because of their fear of the recovery time and surgical complications; the MitraClip could be an alternative for them.
The Repair MR clinical trial will involve about 500 people at 60 sites in the U.S., Canada and Europe. The study will focus on the effectiveness of the MitraClip device in moderate-surgical-risk patients with severe primary mitral regurgitation who are candidates for open-heart surgery.
“We’re pushing the field forward by making clinical investments to examine whether new, minimally invasive treatment options are suitable, or even preferable, to what has been the standard of care,” said Dr. Neil Moat, CMO of Abbott’s structural heart business.
“Devices that can be delivered through a minimally invasive method to close or repair a significant structural issue in the heart are in high demand, and we are committed to continuing our efforts to bring the benefits of these devices to patients who need them,” Moat said in a news release.