STAT+: FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device
“The real questions are, how much uncertainty is there in this assessment of benefit?...How do we weigh that against both the potential harms of the device?"
An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious.
The committee will evaluate data from two companies vying for market approval: ReCor Medical, a startup owned by Japanese company Otsuka Medical Devices, and device giant Medtronic, both of which have made surgical systems to treat hypertension.
Data from an analysis of three randomized clinical trials of ReCor Medical’s device showed a modest decrease in blood pressure after two months compared to a control group that received a placebo procedure. Medtronic’s late-stage trial showed that renal denervation reduced hypertension when measuring blood pressure in the doctor’s office, but did not show a reduction in blood pressure when patients measured it at home over 24 hours. At-home blood pressure is considered the more accurate measure, as blood pressure levels tend to artificially rise with anxiety in the clinic. Neither study presented serious safety concerns.
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