Medtronic (NYSE:MDT) has wrapped up patient enrollment in its Symplicity HTN-3 trial to evaluate company’s renal denervation system and support U.S. approval.
The 530 patient randomized trial will treat patients with either renal denervation and anti-hypertensive medications, or treatment with anti-hypertensive medications alone. The Symplicity device uses a catheter to reduce hyperactive nerves and lower blood pressure in patients who have developed other treatment resistance.
The Centers for Medicare & Medicaid Services (CMS) and the FDA are using Symplicity as one of the first devices in a new parallel review program that will help determine nation-wide coverage as part of U.S. healthcare reform.
"Paralleling the increased prevalence of obesity, treatment-resistant hypertension has emerged as a major health problem in the Western world. 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,” George Bakris, director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine, said in prepared remarks.
The Fridley, Minn.-based medical device company recently released very positive results for Symplicity HTN-2 trial showing significant drop in blood pressure with few adverse events for the 40 patients who received the treatment.
Medtronic also offered a 1st look at results from its global Symplicity registry, finding that treatment with the company’s Symplicity system appears safe as well as effective in real-world patients.
Symplicity is approved for use in 70 countries and is under investigational device exemption in the U.S. and Japan.
