FDA Panel Not Unanimous On MitraClip, But Approval Likely

In short

What a peculiar and unusual series of events the final throes of MitraClip’s progress to FDA approval have been. Recently Abbott has been touting favourable clinical results, making us all believe the company was in good shape to face its FDA panel review meeting yesterday. Then the meeting notes popped up on our screens and we all stared in disbelief as the authors seemed to be pointing the panel in the direction of a no vote.

And then, when the panel did meet, the membersĀ agreed unanimously that the device is safe, and voted 5-3 that the benefits of treatment outweigh the risks. They remained less convinced on the issue of effectiveness.

Background

The FDA’s Circulatory System Devices Panel voted yesterday (March 20th) to recommend the approval of Abbott’s MitraClip heart device. The meeting notes had earlier suggested that the FDA would prefer to see the results of a few additional clinical studies before they would put their weight behind it. On that basis, it will be interesting to see whether the agency now goes along with the vote of its expert panel and approves the device.

The panelists voted 8-0 that the MitraClip implant proved safe in clinical trials and 5-3 that the device’s benefits outweigh its risks. The panel was evenly split 4-4 on the question of effectiveness, prompting a tie-breaking opinion from the panel chair, who voted that the available data did not demonstrate effectiveness for MitraClip.

Is it likely that the FDA will go against its panel recommendation? Well, it’s possible, but it would be unusual for that to happen, even given the less than glowing endorsement for the device’s effectiveness. But the unanimous safety vote should see the product get over the line.

MitraClip has been on the market in Europe since 2008 incidentally.

More on the story here.

Source: healio.com, Massdevice