Medtronic announces renal denervation pivotal trial for hypertension treatment
Medtronic announced U.S. Food and Drug Administration approval to begin an investigational device exemption pivotal trial to evaluate the Symplicity Spyral renal denervation system in patients with high blood pressure. Renal denervation is a minimally invasive procedure intended to regulate the activity of nerves that lead to and from the kidney, which plays an important role in managing blood pressure. The SPYRAL HTN Pivotal Trial is part of the broader SPYRAL HTN Global Clinical Program, a multi-phased clinical study strategy aimed to establish the safety and efficacy of renal denervation to lower blood pressure.The SPYRAL HTN Pivotal Trial is a 1:1 randomized, sham-controlled study to investigate the renal denervation procedure in up to 433 patients at 50 sites in the U.S., Europe, Australia, and Japan. The trial will investigate the blood pressure lowering effect and safety of renal denervation in the absence of medication. The primary efficacy and safety endpoints in the trial are 24-hour blood pressure at three months and incidence of major adverse events through one-month post-randomization. In addition to the results from the SPYRAL HTN-OFF MED trial and the initiation of the SPYRAL HTN Pivotal Trial, new data from the first 80 patients enrolled in the prospective, randomized, sham-controlled SPYRAL HTN-ON MED trial will be presented during the late-breaking clinical trial session at the EuroPCR meeting commencing in May 2018 in Paris, France. This latest phase of the SPYRAL HTN Global Clinical Program will report the initial safety and efficacy of renal denervation six months following the procedure in patients with uncontrolled hypertension despite ongoing drug therapy.