Medical device company Medtronic has announced that the Symplicity HTN-3 study in renal denervation for treatment-resistant hypertension has failed to meet its primary efficacy endpoint.
The clinical study, however, has met its primary safety endpoint. The primary endpoints of the study are the change in office blood pressure from baseline to six months and incidence of major adverse events.
The trial’s Data Safety Monitoring Board concluded that there were no safety concerns in the study.
Medtronic, based on the Symplicity HTN-3 study findings, intends to formulate a panel of independent advisors with physicians and researchers who will be asked to make recommendations about the future of the global hypertension clinical trial program.
In addition, the company also intends to seek advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals.
Also, the company plans to suspend patient 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), pending panel review of the study.
Medtronic chief medical officer Dr Rick Kuntz said, "We are disappointed that the clinical trial failed to meet its primary efficacy endpoint."
"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," Dr Kuntz added.
Based on the above trial results, the company is assessing the carrying value of the renal denervation assets and hopes to incur a one-time impairment charge in the future.
Symplicity HTN-3 is a randomized, controlled trial that was designed to assess the safety and effectiveness of renal denervation with Medtronic’s Symplicity renal denervation system in the US patients with treatment-resistant hypertension and systolic blood pressure higher than 160mmHg.
The clinical trial randomized 535 treatment-resistant hypertension patients in 87 US medical centers.