Medtronic Symplicity Competitors Tread Carefully in Response to Study Failure -

Last week the first sham-controlled Renal Denervation study failed to deliver its end point of a greater than ten point blood pressure reduction in treatment resistant hypertensive patients. ┬áThe fallout was significant with purveyor of the device in question, Medtronic, adopting a considered and “proper” response. Some would say what else could they do but come clean? And indeed it could eventually turn out to have been a PR masterstroke to have made sure they were first out with the news. After all, we’re now going to believe every word that’s issued by a company that has acted so dutifully, like a parent exposing the failings of its own offspring.

But what was the alternative, really? One way or another the poor clinical findings would have leaked out pretty quickly, especially as publication of those very results was scheduled and awaited with bated breath. That the company blurted the results out first and immediately started talking about independent panels and taking on impairment charges on its books was unsurprising from a PR angle. And it has definitely left Medtronic holding the high moral ground. It’s also left them with some breathing space in which the data can be crawled over for signs of good news, all of which is going to look like great news compared with the dark skies predicted last week.

So, what happens next? Well, some clinical commentators have already pointed to their previous predictions that the effect of Renal Denervation might not be as great as early studies had promised. They’re even saying that if the data showed a BP reduction of close to 10 points, while being less than hoped for, might still be enough to justify use of the therapy and indeed save lives. It’s pretty clear there’s a placebo effect, just not how much it has contributed to the earlier claims of drastic and sustained BP reduction.

Medtronic Competitors Staying in the Shadows

Aside from digging up clinical explanations, the really interesting tactical game is starting to evidence itself in the actions of competitors to Medtronic’s Symplicity device. This week sees an annual investorfest, in the form of the JP Morgan Healthcare conference. The hot topic is undoubtedly Renal Denervation in the wake of the Symplicity HTN3 study results. So, who, among the myriad competitors, is going to be the first to gently point out that the original Symplicity device used in the study is a bit old hat and might just be at the heart of the poor results? I mean, they’re all desperate to say it. You can hear the conversations…Should we, shouldn’t we? No, we’d better not… not until we know it’s true.

First to speak was St.Jude, a company probably closest behind Medtronic in the race to US market. Were they about to claim their device would have hit the spot in the same study? After all, it’s quite different to Symplicity, featuring a multi-electrode basket that is quicker and easier to use and probably delivers a less user-dependent dose to the target nerves.

Answer: No. Dan Starks, CEO of St. Jude, Inc., has been about as careful as Medtronic in his stated desire to take a closer look at the data. No big claims there then.

So yesterday, as reported by Massdevice.com, up pops Boston Scientific’s Mike Mahoney… and at last someone’s broken cover! Boston’s recently acquired Vessix system is admittedly different to those of St. Jude and of course Medtronic. It’s a balloon with sensing electrodes on its surface and as such a whole lot more sophisticated than the generation one device at the heart of this discussion. Add to that the claim that in European, ambulatory-based studies it’s performed well. Maybe Vessix is “it”. Sadly Mr Mahoney cannot yet point to a sham controlled study, so as much as he can defend his own device, and in so doing attack the opposition, he’s not quite got the bullets to kill them off yet.

 

 

 

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