Renal Denervation Still Clinging to Non-Sham Study Results? - September 30, 2014
There’s speculation in the air that Renal Denervation might just be back on the agenda as a treatment for hypertension in people who have failed to respond to drug therapy. At least that’s what St. Jude Medical would hope as it has seen data from its most recent study presented at a major congress.
September saw the annual holding of the Transcatheter Cardiovascular Therapeutics meeting, a high profile event that has become the focal point for the very latest developments in one of the fastest evolving specialties.
Presented at the event, the St. Jude EnligHTN III trial, evaluated the company’s renal denervation system of the same name. Investigators found an average office based systolic blood pressure reduction of 23mmHg and an average ambulatory reduction of 10 mmHg after a year.
In comparison with the now famous Medtronic Symplicity study, published earlier in 2014, that sounds pretty good and commentators have pointed to the fact that St. Jude’s device is a lot more sophisticated than Medtronic’s somewhat first generation device as a potential explanation.
Indeed the garden may once again be rosy for renal denervation, albeit with a BP reducing effect significantly lower than the thirty points originally advertised by advocates of the therapy.
EnligHTN III Renal Denervation Study
The problem however, remains in the design of the study, which fails to address the placebo effects so elegantly brought to our attention by the Medtronic study. While Symplicity HTN3 was randomised, blinded and sham controlled, EnligHTN III isn’t.
So is St. Jude plain wrong to continue, or might the new raft of second generation device actually have something that revalidates the therapy? Well, Medtronic remains invested in renal denervation, its own Symplicity Spyral device still in the works. And Medtronic may well have another ace up its sleeve if and when its takeover of Covidien happens, the Massachussetts operation having pulled the plug on its own renal denervation device when the Symplicity news struck. The OneShot device might get a dusting down.
Our guess…and it is a guess, is that the therapy will survive, because of a couple of factors. Firstly, in Europe it’s become an established therapeutic solution for what had been thought to be an intractable condition. Whether by placebo or real effect it seems to be gaining some adoption, although what seems certain is that the dramatic reductions previously advertised won’t stand up to scrutiny.
Secondly, the determination of commercial protagonists to make the therapy work will drive them to get the technology right, and that should and could mean incremental improvements and good earning potential for these big players. They won’t go down without a fight as long as clinical results, good or bad, can be either explainable by the technology or addressable by new technology.
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