Medtronic, Inc. has announced that its U.S. pivotal trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, failed to meet its primary efficacy endpoint. The trial met its primary safety endpoint, and the trial's Data Safety Monitoring Board (DSMB) concluded that there were no safety concerns in the study.
"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, M.D., M.P.H., executive director, Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart and Vascular Center, professor of medicine, Harvard Medical School, and co-principal investigator of SYMPLICITY HTN-3. "Importantly, however, the trial did not meet its primary efficacy endpoint."
George Bakris, M.D., professor of medicine and director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine, past-president of the American Society of Hypertension, and co-principal investigator of SYMPLICITY HTN-3 stated, "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. 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."
In light of the product's demonstrated safety profile, including the SYMPLICITY HTN-3 findings, no specific action is currently indicated for patients who have had the renal denervation procedure with the Symplicity system. Patients should consult with their physician regarding any questions they may have about their treatment.
Based on these clinical trial findings, Medtronic intends to formulate a panel of independent advisors made up of physicians and researchers who will be asked to make recommendations about the future of the global hypertension clinical trial program, as well as provide advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals.
Pending this panel review, the company intends to:
- Suspend enrollment in the three countries where renal denervation hypertension trials are being conducted for regulatory approvals (SYMPLICITY HTN-4 in the U.S., HTN-Japan and HTN-India).
- Begin informing clinical trial sites and investigators, global regulatory bodies, and customers of these findings and decisions.
- Continue to ensure patient access to the Symplicity technology at the discretion of their physicians in markets where it is approved.
- Continue the Global SYMPLICITY post-market surveillance registry and renal denervation studies evaluating other non-hypertension indications.
"We are disappointed that the clinical trial failed to meet its primary efficacy endpoint," said Dr. Rick Kuntz, chief medical officer, Medtronic. "We believe this course of action is the most prudent and will help us thoroughly evaluate these findings and determine the appropriate next steps for renal denervation therapy. We would like to thank the patients and investigators for their participation in the trial and their important contribution to the field of hypertension research."
The company is evaluating the carrying value of the renal denervation assets and based on the above trial results, believes a one-time impairment charge in the future will be likely. The company today reiterated its previously communicated revenue outlook and diluted earnings per share guidance for fiscal year 2014.