Abbott Laboratories’ proposed clamp for leaky heart valves, a less-invasive option to open-chest surgery, may not be effective, U.S. regulatory advisers said.
The Food and Drug Administration advisory panel voted 5-4 that Abbott failed to provide assurances the clamp worked. The panel agreed unanimously that the product, called MitraClip, is safe and voted 5-3 that benefits of its use outweigh the risks.
The votes follow a March 18 report in which FDA staff said Abbott should conduct more research before the agency decides whether to approve what would be the first minimally invasive mitral valve device sold in the U.S. Abbott’s MitraClip is inserted through the femoral vein in the leg where it can then be led to the heart, a procedure that is supposed to be less risky to the patient than traditional open-chest surgery.
“There’s no question we need something like this,” Craig Selzman, a panel member who is an associate professor at the University of Utah School of Medicine in Salt Lake City, said during the meeting today in Gaithersburg, Maryland. “Part of our duty, part of my duty, is to fill this gap for this group of patients.”
Most panel members were concerned that the Abbott Park, Illinois-based device maker looked back at studies with new goals in mind after previous research didn’t work out.
“The efficacy is really the big question and that’s because of the conglomeration of different types of data,” Marc Katz, a panel member who works for St. Mary’s Hospital in Richmond, Virginia, said during the meeting.
The U.S. and European market for transcatheter mitral valve repair and replacement may be a $1 billion opportunity by 2020, Lawrence Biegelsen, an analyst with Wells Fargo Securities in New York, said in a note to clients.
“We are pleased with the outcome of today’s panel, and we look forward to continuing discussions with the agency as it further assesses the MitraClip system,” Charles Simonton, chief medical officer of Abbott’s vascular division, said in a statement.
Mitral regurgitation -- an inefficient pumping of blood caused when leaflets of the mitral valve don’t close properly -- is the most common type of heart-valve disorder, according to the National Institutes of Health. The condition affects 1 in 10 people ages 75 and older, Abbott said.
When the mitral valve doesn’t close all the way, it can lead to a decrease in blood flow to the rest of the body. The heart may try to pump harder to compensate and cause congestive heart failure, NIH said on its website.
The FDA staff said a study known as Coapt, conditionally approved by the agency in February 2012, will provide better data that may support approval of the device. Researchers are estimated to conduct final data collection in January 2017 and complete the study in August 2019, according to NIH’s clinicaltrials.gov.