Is Last Year’s Watchman LAA Occlusion Device Approval Another Example Of Low European Regs Bar?

We’ve reported a couple of times recently on the subject of Boston Scientific’s Watchman device, a percutaneously inserted plug that sits in the mouth of the Left Atrial Appendage and in so doing prevents clots forming and breaking free during bouts of atrial fibrillation.

We’ve also written extensively on the subject of European Medical Device Regulation and the commonly held view that for certain products it remains remarkably easy to get to market when compared with the U.S. Pre-Market Approval (PMA) process.

Scene set then, today we have European medical device industry body Eucomed launching its “don’t lose the 3” campaign, built around ensuring that new technologies get to market quicker, and in so doing save lives and livelihoods.

As if it’s not thought-provoking enough that two civilised societies can operate diametrically opposed systems, what should really shake the casual observer is that there is no obvious better way: Every fibre of our being says we need as much evidence as possible before we allow a high risk device onto the market. Yet equally, every fibre of our being would want the most up to date technology using on ourselves or our loved ones.

But does new always mean good? I’m not a medical professional in any capacity, but I do have a reasonable handle on the technology. And when I see a new idea start gaining airtime, my naturally scientific perspective wonders whether what I’m seeing is a step forward or a blind alley. There are plenty of examples of both out there.

We don’t yet know where Boston Scientific’s Watchman LAA device fits into the future armoury of the cardiologist. If you read the blog of the brilliant cardiac electrophysiologist John Mandrola on heartwire (here), you’ll conclude that serious questions remain. On a long list of points he remains unconvinced, not least the fact that by inserting a Watchman, one is inserting into the heart a permanently indwelling device. Not only that, but he has doubts about the efficacy stats and the fundamental premise of this approach.

John Mandrola is clearly a clever chap. One might argue that he’s better qualified to make judgements about indwelling heart devices than most. What one might also argue is that he’s a tad better qualified than any auditor attached to a European notified body, simply by dint of his specialisation vs their generalisation.

So when he says he wouldn’t have an LAA device inserted in him, I listen.

And when an EU notified body issues a CE certificate to say it’s safe, I don’t. Why not? Because I know the supportive data required and the bloke making the call are simply not up to snuff in any comparative sense. So what do I do next? I look for the data used to support the approval and guess what…it’s not available. At least if it was I’d be able to make up my own mind or watch the experts doing so for me.

So, yes the EU gets there first. And actually Amen to that, because if all Western world markets had universally high bars,  many devices would simply never make it, their developers running out of money long before they’d got in sight of  any revenue. When Eucomed nails its colours to the mast of easier approval, an argument based on a record of few problems, we have to agree that’s pretty compelling. But when a prominent and adequately qualified physician says he has doubts, shouldn’t we wonder, just a little bit, whether the CE mark is just a bit too easily come by.