FDA committee doesn’t recommend Abbott’s heart device for approval

Hannah Blake

pharmaphorum

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration.

Clinical trials, called EVEREST, involved 351 symptomatic US patients deemed too high risk for open mitral valve surgery. Results showed a 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system versus 18.2% predicted surgical mortality) and an implant success rate of 96%.

However, in a document published on the FDA website, reviewers from the Division of Cardiovascular Devices within the Center for Devices and Radiological Health at the FDA deemed the clinical trial data of MitraClip “difficult to interpret” and cited a lack of “valid scientific evidence” of safety and effectiveness.

MitraClip is an investigational device and the company’s first-in-class catheter-based system for the treatment of mitral regurguitation (MR). MR is the most common type of heart valve insufficiency, which affects approximately one in 10 people aged 75 years and older.

Abbott recently changed the proposed use for the device, following concerns expressed by the FDA that there was a lack of evidence to support its approval for a broader use in patients with significant mitral valve insufficiency.

The FDA document has been published ahead of its meeting with Abbott on the 20th March.

"These results add to the large and growing body of data that show that the first-in-class percutaneous MitraClip therapy can have positive results for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation. We look forward to the March 20 FDA Advisory Committee meeting to discuss the MitraClip system as a treatment option for this patient group in the United States."

Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.