Renal denervation technologies took another blow this week as 1-year results from Medtronic‘s (NYSE:MDT) much-lamented Symplicity HTN-3 trial still turned out no signs that the treatment is effective against hypertension.
The 12-month results, which included 6-month results from patients who switched from the control arm to the renal denervation arm, still haven’t found signs that renal denervation lowers blood pressure better than a sham treatment.
The new results showed no significant different in blood pressure reductions among the original renal denervation patients, those that crossed over into the renal denervation arm and those who remained in the sham arm, Medscape reported.
The good news is that the technology continues to have a strong safety profile and the ongoing study has helped researchers make some progress in their understanding of the renal arteries and their role in hypertension.
"What we learned since the original results were presented at the ACC is that the anatomy of the renal nerves is much more complex than we thought," co-principal investigator Dr. George Bakris said during a presentation at this year’s European Society of Cardiology Congress. "There’s a lot of procedural things being learned and anatomic things being learned, so I would say this is a work in progress."
The Symplicity HTN-3 study, largely expected to be a slam dunk for Medtronic, failed to meet the efficacy endpoint in a U.S. pivotal trial. The news sent a shock wave through the medical device world, prompting Covidien (NYSE:COV) to ditch its RDN program. The 2 other major players in the RDN space, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ), lowered their financial expectations for their RDN offerings, the Vessix and EnLightn devices, respectively.
Nonetheless, the treatment has managed to gain ground in clinical practice, especially in Europe where the procedure is already approved.