Evidence in Medtech: Should Renal Denervation’s Fall from Grace Restore our Faith?

The fallout from Medtronic’s Symplicity HTN-3 Renal Denervation study just keeps coming. This week we’ve even seen one medtech giant pull out of the business, a year after their first sale. We deliberate about what it all means for the regulators and the evidence lobby.

The last few weeks have been unprecedented. Not in our memory has such a promising technology taken such a rapid nosedive based on one study, but that’s what seems to be happening to Renal Denervation as a therapy to treat resistant hypertension.

The resultant pondering about what this means for the evidence lobby remains to be seen. After all, here’s a technology that has come into question as soon as a sham controlled blinded study hit the streets. Does that mean all other devices and therapies that don’t have such studies behind them should be questioned?

Most interesting will be the reaction in markets where Renal Denervation has been approved for the blood pressure indication. Is there any egg on the faces of regulators or lawmakers? What should healthcare providers be doing right now? Continuing to spend our money on the therapy or ditching it for lack of efficacy evidence?

It’s a can of worms and no mistake. Read our assessment in this week’s View From the Med, here.

published: January 24, 2014 in: medlatest Editorial

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