Medtronic has completed randomizing Symplicity HTN-3, a clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension.
Renal denervation is a minimally invasive, catheter-based procedure that decreases the activity performed by the renal nerves, which help regulate blood pressure.
Although available in more than 70 countries, the Symplicity renal denervation system is available only for investigational use in the US and Japan.
It is one of the first medical devices to participate in the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) parallel review program, which will allow the CMS to begin national coverage determination while the FDA completes its review of safety and efficacy.
Clinical trial data of the Symplicity HTN-3 will be an important aspect of the parallel review.
University of Chicago Medicine ASH Comprehensive Hypertension Center medicine professor and Symplicity HTN-3 co-principal investigator George Bakris said that paralleling the increased prevalence of obesity, treatment-resistant hypertension has emerged as a major health problem.
"The results of this study will provide the medical community with data that will not only further our understanding of the impact of renal denervation on treatment-resistant hypertension, but also potentially help bring a new treatment option to people in the U.S. affected by this condition," Bakris added.
Symplicity HTN-3 is Medtronic’s first blinded, randomized, controlled trial designed to assess the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension.
The trial randomized 530 patients across nearly 90 medical centers in the US to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications.
The study’s primary endpoints are the change in blood pressure from baseline to six months following randomization and the incidence of adverse events one month following randomization and renal artery stenosis to six months.
Symplicity HTN-3 co-principal investigator Deepak L Bhatt said, "The Symplicity HTN-3 study investigators and research coordinators should be recognized for their leadership in addressing initial recruiting challenges to complete this seminal clinical trial."