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Last year's confirmation that renal denervation could lower blood pressure in patients off hypertension medications justifies a pivotal trial for the Symplicity Spyral system, the FDA decided.

Manufacturer Medtronic the investigational device exemption approval of the SPYRAL HTN Pivotal Trial, a randomized, sham-controlled study evaluating the device in up to 433 patients at 50 sites in the U.S., Europe, Australia, and Japan. Eligible patients will be those not taking blood pressure-lowering drugs.

The primary efficacy and safety endpoints of the trial are 24-hour blood pressure at 3 months and major adverse events through 1 month after randomization, respectively.

"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, of Atlanta's Piedmont Heart Institute, and principal investigator in the study, said in a statement.

Kandzari referred to the SPYRAL HTN-OFF MED trial, which showed that renal denervation with Symplicity Spyral's novel catheter was associated with significant, albeit mostly single-digit drops in blood pressure through 3 months. The senior investigator had called it "biologic proof of concept" for renal denervation, as 番茄社区app reported last year.

The next trial in the series, SPYRAL HTN-ON MED, will provide data on a separate hypertensive cohort that received radiofrequency ablation with the device while staying on hypertension medications. This is expected to be presented at the EuroPCR meeting this May.

Altogether, the latest trials are intended to reverse the blows dealt to renal denervation using the Symplicity device when the SYMPLICITY HTN-3 trial results were reported in 2014.

Since then, the catheter has been redesigned -- Symplicity Spyral has more electrodes to deliver up to four simultaneous radiofrequency ablations in a helical pattern -- and treatment of branch vessels has been added to the technique.

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