Be honest… can you honestly say that as you toasted the New Year in, you were expecting Covidien to be pulling out of renal denervation less than three weeks later? The company has announced it will exit its OneShot™ Renal Denervation program primarily, it says, in response to slower than expected development of the renal denervation market.
Almost exactly a year ago we were reporting the launch of the OneShot system, following Covidien’s May 2012 acquisition of Maya Medical. OneShot is another of the many stabs at Renal Sympathetic Denervation, this time a balloon-based system rather like Boston Scientific’s Vessix device.
Now, 12 months on, Covidien is ditching the device and presumably mentally writing off the $60 million it spent on buying Maya as a bad job. In a newly issued press release, Covidien says it will not proceed with its RAPID II randomized study. Additionally, Covidien expects to record after-tax charges in the range of $20 to $25 million as a result of exiting the OneShot program.
The medtech giant says its decision results from a “regular review of strategic programs and growth potential for various aspects of its product portfolio”. And while it’s probably the case that EU sales have been, like everyone else’s, below rose-tinted expectations, there will be speculation that coming a week after the failure of Medtronic’s Symplicity HTN-3 study to deliver its efficacy end point, they’ve decided it’s too big a hill to climb, for too little reward.
Now Covidien has the headache of making those uncomfortable calls to physicians and the renal denervation community to ensure existing OneShot patients are informed and the currently enrolling clinical trials are transitioned appropriately.
So is that it? One study from Medtronic and they’re dropping like flies? Seems odd that, especially when noted commentators are urging all of us to spend a bit of time taking stock. We haven’t even seen the Symplicity data yet, although it’s been predicted that the reduction in blood pressure in a severe and treatment resistant population might be looking more like 10mmHg rather than the 30mmHg promised by earlier studies. Nobody has yet come up with an explanation that looks anything other than speculation, and quite sensibly the other clinical studies are in a bit of a limbo state until probably after the March American Cardiology meeting when the luminaries will be passing judgement.
If, as experts say, 10mmHg is equivalent to one drug program, one might have thought there was still mileage in the therapy. At least enough to then see whether other, more sophisticated systems than the Symplicity single electrode affair, might work better. Or at least enough to warrant entering a holding pattern til the dust settles.
Patients aren’t good at sticking with drug courses, so one shortish procedure sounds like it could be a viable alternative in some cases. Seemingly not viable enough to maintain Covidien’s interest. Their early exit might of course lead to speculation that OneShot clinical outcomes are also disappointing. But surely the community needs to rapidly come to some conclusions here, because without a considered position the speculation is going to keep on coming and we might all just end up throwing out the baby with the bathwater.
Source: Covidien, plc.