Correction: March 20, 2013, at 11:40 a.m.: This article mistakenly stated that the FDA’s advisory panel recommended against approval for MitraClip. The recommendation came from the FDA’s internal reviewers prior to the panel meeting.
The FDA isn’t convinced that Abbott’s (NYSE:ABT) MitraClip mitral regurgitation treatment device is safe and effective, and the agency recommend against premarket approval for the implant.
The FDA concluded that the clinical trial data available for the catheter-based MitraClip system is insufficient to demonstrate safety and efficacy. The FDA has worked with Abbott to develop a new trial and to gather additional data that may later support a win, the agency noted.
The FDA’s Circulatory System Devices Panel is scheduled to meet tomorrow to consider the results of the agency review and issue a final vote regarding MitraClip. If approved, MitraClip would be the 1st minimally invasive mitral valve regurgitation implant on the U.S. market.
The system is comprised of a delivery catheter, a steerable sleeve and the MitraClip percutaneous mechanical clip. Abbott hopes to win indication to reduce significant, symptomatic mitral regurgitation in patients too sick to undergo open-heart surgery.
"The FDA believes that the analyses provided in the PMA are interesting and important," according to the report. "FDA believes these analyses are hypothesis generating and do not constitute valid scientific evidence of safety and effectiveness for the MitraClip CDS for the proposed Indication for use in an inoperable MR population."
The agency recommended that MitraClip remain available to a narrow group of patients treatable under the device’s Investigational Device Exemption and through clinical trials, and that Abbott continue collecting data to support future approval for the device.
"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 FDA added.