|The FDA wants more data before considering approval for Abbott Laboratories' MitraClip.--Courtesy of Abbott Laboratories|
FDA staff is recommending against approving Abbott Laboratories' ($ABT) MitraClip System, saying the company's data doesn't quite prove the device's safety and effectiveness.
The device is designed to improve outcomes for patients with mitral regurgitation at high risk for surgery, and Abbott has been touting positive results from its EVEREST II trial, saying MitraClip contributes to a lower mortality rate and higher quality of life.
However, after reviewing the data, the FDA says MitraClip did not demonstrate good enough risk-benefit results over traditional mitral valve surgery, and the study didn't prove it to be much safer, either.
"PMA approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered," the agency wrote, recommending that MitraClip stay investigational as Abbott amasses more data from its ongoing trials in the U.S. and abroad.
The staff note comes before Abbott has to face the FDA's Circulatory System Devices Panel on Wednesday, where the company hopes to get a recommendation for approval. If the panel concurs with FDA staff and delays the approval process, Abbott's planned MitraClip rollout could be indefinitely delayed.
Abbott, however, remains undaunted, pointing out that U.S. patients at too high a risk for valve surgery have no other options to treat mitral regurgitation and improve their quality of life.
"The MitraClip device represents a true advance for these patients, and we look forward to discussing the totality of the clinical evidence with the advisory committee and hearing its recommendation on Wednesday," Abbott said in a statement provided to FierceMedicalDevices.
Mitral regurgitation occurs when the mitral valve fails to close all the way, leading to inefficient blood flow that can lead to heart failure. Analysts estimate the worldwide market for transcatheter mitral valve repair could reach $1 billion a year by 2020, Bloomberg reports.
Editor's note: This story was updated to include comments from Abbott.