FDA, CMS to review Symplicity simultaneously

The FDA and the Centers for Medicare & Medicaid Services (CMS) will conduct a parallel review of Symplicity, a renal denervation system for treatment-resistant hypertension. The review allows CMS to begin consideration for national coverage determination while the FDA completes its review of the safety and efficacy.

The parallel review will be based primarily on results from the U.S. clinical trial Symplicity HTN-3, according to Minneapolis-based Medtronic. Symplicity HTN-3 is a single-blind, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation in patients with drug-resistant hypertension. Renal denervation lowers blood pressure in patients with drug-resistant hypertension by using a percutaneous, catheter-based technique to disrupt overactive renal sympathetic nerves.

Symplicity HTN-3 will randomize 530 patients in up to 90 U.S. medical centers to either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone. The study's primary endpoints are the change in blood pressure from baseline to six months following randomization and incidence of major adverse events one month following randomization.

Findings from another study, Symplicity HTN-2, showed benefits persisted at one year while control patients who crossed over to renal denervation after the six-month primary endpoint was met experienced drops in blood pressure similar to the treatment group. Three-year results from the nonrandomized Symplicity-1 trial demonstrated that the clinical response was sustained through three years and there was no loss of treatment effect over time.

For more information on renal denervation, please read “The Newest Frontier in Cardiac Care: Kidneys” in the winter issue of Cardiovascular Business.