Amid the hand-wringing and back-pedaling surrounding renal denervation, some physicians are still looking for ways to use the technology to treat patients with hypertension.
Although Medtronic’s (NYSE:MDT) landmark SYMPLICITY HTN-3 clinical trial found that the technology was no better than a sham treatment, interest and hopes remain high that there may be more to the study than the bottom line.
"What could happen is we say, ‘this isn’t working, so we’ll stop,’" Dr. Felix Mahfoud told Medscape. "But the problem I have with that is this [technology] is too young and too promising to stop now."
This month’s EuroPCR conference in Paris was host to no fewer than 60 sessions about renal denervation, some of which raised eyebrows from attendees who worried that the focus was shifting toward marketing rather than science.
Other doctors lauded the renewed spotlight for renal denervation, saying that conference organizers had rightly taken the initiative to spur more conversation on the technology in the aftermath of SYMPLICITY HTN-3.
"We’re learning that this is much more complicated than we originally thought," Mahfoud said. "It was a very important trial, and it made us all stop and [ask]: How we could improve the technology? What are the next future studies?"
This year’s sessions covered everything from patient selection to proper ablation technique, some raising questions about the quality of SYMPLICITY HTN-3 and others examining whether the data suggested certain patient groups that might be better candidates for renal denervation treatment.
Medtronic earlier this year rocked the industry when it reported that its SYMPLICITY HTN-3 clinical trial failed to find that renal denervation was more effective than a placebo in bringing down patients’ blood pressure. The landmark trial is the most stringent yet to examine renal denervation, with blinding, a sham control arm and ambulatory blood pressure readings providing an unprecedented look at the technology.
The trial proved that the treatment was safe, but found no statistically significant effect compared with a sham procedure, resulting in the closure of some renal denervation programs, delays in others and write-downs among the top device makers.
Some physicians have thrown in the towel on the technology, but others have urged patience as more research attempts to tease out the cause of the disparity between SYMPLICITY HTN-3 and the successful clinical trials that came before.
No renal denervation system has been approved by the FDA for marketing in the U.S., but the technology has been on the European market for years.
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