Medtronic, a world leader in medical device technology, with the involvement of The Heart Hospital at Baylor Plano and the Baylor Jack and Jane Heart and Vascular Hospital at Dallas, finished randomizing the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension.
Symplicity HTN-3 is Medtronic’s first blinded, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension in the U.S.
The trial randomized 530 patients across nearly 90 medical centers in the U.S. to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone.
Baylor’s two sites were consistently among the top three U.S. sites for both enrollment and randomization.
“Because patients had to meet the most strict inclusion criteria of any renal denervation clinical trial to date, enrollment in Symplicity HTN-3 was at first challenging,” said Deepak L. Bhatt M.D., M.P.H., co-principal investigator.
“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.”
Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure.
The Symplicity renal denervation system is available in more than 70 countries worldwide; it is only available for investigational use in the U.S. and Japan.
The Symplicity renal denervation system is also 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.