April 9, 2018
FDA Approves Medtronic's Pivotal Trial to Evaluate Renal Denervation to Treat Hypertension
April 9, 2018—Medtronic announced US Food and Drug Administration approval to begin an investigational device exemption pivotal trial to evaluate the company's Symplicity Spyral renal denervation system in patients with hypertension.
According to the company, 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 United States, Europe, Australia, and Japan. The trial will investigate the blood pressure-lowering effect and safety of renal denervation in the absence of medication.
The global pivotal trial will support approval and adoption in new geographies for the therapy, which is currently approved for commercial use in more than 50 countries. The Symplicity Spyral system is limited to investigational use in the United States and Japan, advised Medtronic.
The primary efficacy and safety endpoints in the trial are 24-hour blood pressure at 3 months and incidence of major adverse events through 1 month after randomization. The SPYRAL HTN pivotal trial is part of the broader SPYRAL HTN global clinical program, a multiphase clinical study strategy aimed to establish the safety and efficacy of renal denervation to lower blood pressure.
In the company's announcement, the study's Principal Investigator David Kandzari, MD, commented, "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.” Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia.
The study's Coprincipal Investigator Raymond Townsend, MD, added, “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.” Dr. Townsend is a member of the Medtronic Executive Committee that designed and oversees the SPYRAL HTN global clinical program. He is Director of the Hypertension Program at the Hospital of the University of Pennsylvania and Professor of Medicine with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania.
The company also advised that 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 held on May 22–25, 2018 in Paris, France. This latest phase of the SPYRAL HTN global clinical program will report the initial safety and efficacy of renal denervation at 6 months after the procedure in patients with uncontrolled hypertension despite ongoing drug therapy.