Abbott Laboratories needs to conduct more research on its proposed clamp for leaky heart valves before U.S. regulators can decide whether to approve the device, Food and Drug Administration staff said today.
Agency staff said Abbott’s current data don’t prove the safety or effectiveness of what would be the first minimally-invasive mitral valve device sold in the U.S. Advisers to the FDA are scheduled to meet March 20 to weigh approval of the Abbott Park, Illinois-based company’s product.
The 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 methods. 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 March 7.
Abbott’s analyses provided in its application for approval “are interesting and important,” FDA staff said in a report released today. “However, for the reasons discussed above, FDA believes these analyses are hypothesis generating and do not constitute valid scientific evidence of safety and effectiveness.”
Patients who are considered too high risk for surgery don’t have satisfactory options to treat the disease and suffer from poor quality of life, Jonathon Hamilton, an Abbott spokesman, said in an e-mailed statement.
“The MitraClip device represents a true advance for these patients, and we look forward to discussing the totality of the clinical evidence with Advisory Committee and hearing their recommendations,” Hamilton said.
Abbott declined 2 percent to $33.46 at the close in New York. The company has increased 18 percent in the past 12 months.
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 one in 10 people age 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 the Coapt trial the agency conditionally approved in February 2012 will provide better data that may support approval. Researchers are estimated to conduct final data collection in January 2017 and complete the study in August 2019, according to NIH’s clinicaltrials.gov.