Medtronic has announced US FDA approval to begin an investigational device exemption (IDE) pivotal trial to evaluate its Symplicity Spyral renal denervation system in patients with hypertension. The SPYRAL HTN pivotal trial is part of the broader SPYRAL HTN global clinical programme—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 randomised, sham-controlled study to investigate the renal denervation procedure in up to 433 patients at 50 sites in the USA, 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-randomisation.
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, randomised, sham-controlled SPYRAL HTN-ON MED trial will be presented during the late-breaking clinical trial session at EuroPCR 2018 (22–25 May, Paris, France). This latest phase of the SPYRAL HTN global clinical programme will report the initial safety and efficacy of renal denervation six months following the procedure in patients with uncontrolled hypertension despite ongoing drug therapy.
The study’s principal investigator David Kandzari, director of interventional cardiology and chief scientific officer, Piedmont Heart Institute in Atlanta, USA, says: “We are entering a new era for blood pressure control with data from a rigorous sham controlled trial showing that renal denervation significantly lowered blood pressure in the absence of antihypertension medications.”
Raymond Townsend, director of the Hypertension Program at the Hospital of the University of Pennsylvania, a professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania (USA), and co-principal investigator in the trial, comments: “We understand the renal denervation procedure much better than we did just a few years ago, and our growing body of clinical evidence strongly suggests that this unique procedure can positively impact patients with high blood pressure.”
Approved for commercial use in more than 50 countries around the world, the Symplicity Spyral system is limited to investigational use in the USA and Japan.