MASSDEVICE ON CALL — Dr. George Bakris, the co-principal investigator for Medtronic‘s (NYSE:MDT) failed Symplicty-3 renal denervation trial, believes further clinical work should be tabled until a few key questions about the therapy are answered.
Bakris, in a commentary for MedScape.com, said there’s no question that renal denervation works, citing the therapy’s 40-year history of study. But the failure of the Symplicity-3 trial to meet its efficacy endpoint raises important questions about how to use renal denervation for hypertension, he said.
"Does renal denervation work? No question about it. It wouldn’t be around today if it didn’t. It’s been studied for over 40 years. It definitely works, but in the absence of anything else," he told the website. "The question that a lot of people are asking is, ‘Is renal denervation dead?’ As they said at [American College of Cardiology] opening ceremonies, what we have here is the prologue.
"We need to look at [Symplicity-3] and figure out what went wrong. Is it the case that everybody got denervated properly and people in the trial were taking their drugs, but in the real world they’re not? Could that be the reason? Or was there a problem with the procedure?"
Bakris credited Medtronic with "forging ahead" to examine how nerves are distributed along the renal artery. Speculating that there are more nerves near the kidney, Bakris said the optimal location for denervation hasn’t been discovered.
"Where did you denervate? Did you denervate deep there [nearer the kidney]? Did you come back? These are all unanswered questions," he said. "I don’t think another clinical trial should be done by anybody, because nobody knows this information. It’s not like somebody knows and it’s a secret. Nobody knows this, and if you go forward without knowing this information and get another negative trial, then the assumption is that it really must not work, so forget it. Then it will die.
"I think a little patience and a little more knowledge would be wise at this point. That’s my 2 cents."
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