Today’s Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients.
The indications for the MitraClip Clip Delivery System that were being discussed were “the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3+) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the mitral regurgitation.”
In the end, the panel voted on three questions which relate to the approvability of the device, and the envelope goes to…well here are the votes:
(1) Is there reasonable assurance that the Abbott Vascular MitraClip CDS is safe for use in patients who meet the criteria specified in the proposed indication? The vote was 8-0 in favor.
(2) Is there reasonable assurance that the Abbott Vascular MitraClip CDS is effective for use in patients who meet the criteria specified in the proposed indication? Here the vote was a tie, so the head of the panel broke the tie and not in favor of efficacy. The vote was 5-4 against.
(3) Do the benefits of the Abbott Vascular MitraClip CDS for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication? Here, although the panel voted against efficacy, the safety profile was strong enough so that they felt the risk:benefit ratio was favorable. The vote was 5-3 in favor.
So a recommendation for approval now goes to the FDA itself. It’s important to understand that this panel only provides a recommendation to the FDA. The Agency will most definitely be holding continuing talks with Abbott Vascular, the manufacturer, before making a final determination.
The MitraClip has been approved in Europe (over 40 countries, in fact) for four years now, but patients in the U.S. have only been able to get it under an investigational exemption (part of a randomized trial) or via “compassionate use” criteria. Several of the commenters on Twitter were pointing out the fact that, if the MitraClip does not get approved and the FDA requires yet another trial, it would be five years before U.S. patients could benefit from this device.
For some background on the MitraClip, read my article from back in the day (that would be 2010), “Catheter-Based Mitral Valve Repair Compares with Open Heart Surgery at One Year.”
I was struck by Dr. Ted Feldman’s comment from that article:
“The most striking thing in our experience is the remarkable clinical response.
“I’ve had patients who literally could not walk across the road without getting shortness of breath and who go home after this procedure and, in less than a week, are doing water aerobics.”
And stories from patients, ostensibly brought in by Abbott, seemed to be of some influence in today’s panel hearing. As Michael O’Riordan (@mikeheartwire) of theheart.org tweeted: “See, one panelist says it was very easy to be swayed by great stories. So patient advocates do matter! #mitraclip #fda”
Yes they do!
Reminds me of an FDA hearing back in the day (that would be 2006) about late stent thrombosis with drug-eluting stents. Articles like Bob Bozell’s reference to “patients walking around with tiny time bombs in their hearts” had caused quite a stir, and brought a patient to Angioplasty.Org’s Patient Forum where he found out about the hearing and, after several long phone chats with me, finally testified.
There was no doubt that his testimony had an effect on the panel. The discussion moved just a bit away from talking about statistics, data and PowerPoint slides, and a bit towards the patient!..many of whom were scared by these “dreadlines” and looking for guidance. (See “Patient Stories: Rick Dulin Speaks to the FDA.”)
Also kudos to @mikeheartwire @Cardiology @theheartorg @MedDevicesDaily @MedDeviceMark for live tweeting the FDA panel hearing!!
Late Update: Read Abbott’s statement on today’s panel hearing, “FDA Panel Recommends MitraClip for Approval.”