FDA Announces IDE Trial for Medtronic's Symplicity Spyral Renal Denervation System

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The device is approved for commercial use in more than 50 countries but is limited to investigational use in the United States and Japan.

The US Food and Drug Administration (FDA) announced its approval for an investigational device exemption (IDE) pivotal trial in order to evaluate Medtronic’s Symplicity Spyral renal denervation system in patients with hypertension.

Dubbed the SPYRAL HTN Pivotal Trial, the study will be part of Medtronic’s SPYRAL HTN Global Clinical Program, overseen by Raymond Townsend, MD which aims to determine the efficacy and safety of renal denervation, a minimally invasive procedure, to lower blood pressure.

The device is approved for commercial use in more than 50 countries but is limited to investigational use in the United States and Japan.

"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," David Kandzari, MD, the director of interventional cardiology and chief scientific officer of the Piedmont Heart Institute in Atlanta, Ga., and principal investigator in the study, said in a statement.

The trial will be a randomized, sham-controlled investigation of the procedure in up to 433 patients at 50 locations in the US, Europe, Australia, and Japan, with the primary efficacy and safety endpoints being 24-hour blood pressure at 3 months and the incidence of major adverse events 1-month post-randomization, according to Medtronic.

Hypertension increases the risk of myocardial infarction, stroke, and heart and kidney failure, leading it to be the largest contributor to cardiovascular death. Annual direct costs of the condition are estimated at $500 billion globally, and almost 20% of patients are completely non-adherent to oral medications while nearly half are at least partially non-adherent, highlighting the need for more therapeutic options.

"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," Townsend, the director of the Hypertension Program at the Hospital of the University of Pennsylvania, a professor of Medicine in the Perelman School of Medicine, and co-principal investigator in the trial, said in a statement.

Additionally, Medtronic noted that the data on safety and efficacy information from the first 6 months following the procedure in 80 patients of the SPYRAL HTN-ON MED trial, the latest phase of the SPYRAL HTN Global Clinical Program, will be presented at the May 2018 EuroPCR meeting in Paris, France.

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