Mitral Valve Patients Urged To “Hold On” Until MitraClip Gets The Nod

Thought-provoking though isn’t it? And the thought I hope it’s not provoking (in Europe) is that we need to replicate the FDA’s “considered” pace of regulatory approval.

Abbott’s MitraClip is probably towards the more extreme end of the scale when it comes to devices that demonstrate the differences between EU and US approval of high risk products. CE marked in 2008 and now with over 4500 patients under its belt the device has clearly found a home in Europe. And why wouldn’t it? Mitral valve insufficiency, for which MitraClip is a treatment option, is a horrible and life-limiting condition. It’s characterised by pulmonary oedema among a no doubt considerable list of concomitant ailments and patients are often too sick for conventional surgery.

We’ve covered the patient angle on our pages, most recently the tale of Karen Pomer who believes MitraClip gave her mother both quality and quantity of life at the age of 92 (under MitraClip’s IDE). Her story formed part of the data submitted to the FDA circulatory devices panel review meeting a few weeks ago in support of MitraClip. Of course she’s no more of a clinical expert than anyone else, but she’s clearly reflecting the view of some people who are.

We know MitraClip’s safe. We know (from EU experience) that it’s likely to be reserved for the most needy patients, for whom no other form of surgery is an option. We know patients tolerate the procedure and respond well to the device (80% good results). And we also know that cardiologists aren’t stupid and won’t start banging these things in willy nilly. Yet such is the defensive nature of the FDA that it is not likely to approve the device until it’s dithered a bit longer. And this is clearly starting to niggle the cardiology community that is keen to do the right thing by its patient group, for whom no other option is doing the trick. Indeed, in an article published in the past few weeks on, cardiologist Melissa Walton-Shirley is offering up an impassioned plea to her patients to “hold on”…until the regulator says you can have your life saved.

That might be a bit of an overstatement (on my part) of the potential for MitraClip, but goodness me, it sounds strange doesn’t it? Over here in the supposedly relatively neanderthal European Union we’re tooled up with some marvellous gizmos that clearly hit the spot. While in the United States, with its technological superiority, deeper pockets and reputation for clinical excellence, expert physicians are not allowed routine access to a device that they are screaming could help their patients. And it’s not a mad inventor’s latest brainwave, it’s a device with years, thousands of patients and good clinicals behind it.

Now I’m no statistician, and I’m quite prepared to believe that 4500 implants doesn’t make the device brilliant, in the same way that driving all my adult life doesn’t make me Michael Schumacher. But really, isn’t there even the slightest consideration given to what happens outside the U.S when considering approving a product?

The contrarian position is that the data doesn’t yet fully stack up… even the circulatory devices panel didn’t fully support MitraClip from the data on efficacy. So how on earth can those slack European regulators have let this one out of the cage? And were they right to do so?

I’m thinking Dr Walton-Shirley might have hit the nail on the head when she “winces with shame” about the pace of approval in the U.S. But then again, we could equally be wincing with shame at the speed (and presumably lack of supportive data) with which this device hit the shelves in Europe.

Well, we could, but we’re not, because it clearly offers something cardiologists need and as is the way with these things the market is talking.

Thought-provoking though isn’t it? And the thought I hope it’s not provoking (in Europe) is that we need to replicate the FDA’s “considered” pace of regulatory approval.

Written by Nick Woods, editor,


Please note by the way, that I’ve read this through and you could be forgiven for thinking we’re in some way supported by medical device companies such as Abbott. I’ve said it before, but I’ll say it once more, for the avoidance of doubt: Medlatest is wholly independent and fee to express its views as part of its mission to make sure we, industry, medical professional, investor, watcher, patient, are all up to speed with what’s going on. We’re advocates for technology delivered the right way, in the interest of patients, not for any specific company or companies.