SYMPLICITY HTN-3 Fails to Meet Primary Efficacy Endpoint
The SYMPLICITY HTN-3 trial — the critical U.S. trial in renal denervation for treatment-resistant hypertension — failed to meet its primary efficacy endpoint, according to an announcement made Jan. 9 by the trial’s sponsor Medtronic, Inc.
“SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak L. Bhatt, MD, MPH, FACC, co-principal investigator of SYMPLICITY HTN-3. “Importantly, however, the trial did not meet its primary efficacy endpoint.”
“While it's disappointing the trial did not meet its primary efficacy endpoint, this is the most rigorous renal denervation clinical trial conducted to date, and the first of its kind to include a sham-control group,” adds George Bakris, MD, co-principal investigator of SYMPLICITY HTN-3. “We look forward to advancing these data into the peer-review process and will submit these findings for presentation and scientific discussion at an upcoming scientific congress.”
Medtronic is current evaluating the carrying value of the renal denervation assets. Based the trials results, the company believes a one-time impairment charge in the future is likely.
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