The US Food and Drug Administration (FDA) has approved Medtronic’s Symplicity Spyral renal denervation system for the treatment of hypertension, the company has announced.
The Symplicity Spyral system, also known as the Symplicity blood pressure procedure, provides a catheter-based approach to denervate the renal arteries using radiofrequency energy.
Back in August, the FDA’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral system is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use, as reported by Medscape Medical News.
As part of the Medtronic SPYRAL HTN Global Clinical Program, more than 25,000 patients have been treated worldwide, both in the presence and absence of medication, and in patients with high baseline cardiovascular risk.
The SPYRAL HTN-OFF study enrolled patients with hypertension whose medications could be stopped at the start of the trial.
The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months after renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device compared with sham-control patients.
The SPYRAL HTN-ON study evaluated patients with uncontrolled hypertension who continued taking their blood pressure medications during treatment with either the Spyral renal denervation device or a sham device.
The primary endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03 mm Hg reduction in ambulatory systolic blood pressure in active-treatment patients compared with sham-control patients.
“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients,” David Kandzari, MD, chief, Piedmont Heart Institute, and co-principal investigator of the SPYRAL clinical program, said in the news release.
“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” added co-principal investigator Raymond Townsend, MD, with University of Pennsylvania School of Medicine.
Medtronic notes that patient preference and shared decision-making are key components when considering the Symplicity blood pressure procedure.
In a patient preference study led by Medtronic, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one third of patients were likely to choose the interventional treatment.
Earlier this month, the FDA also approved the Paradise Ultrasound Renal Denervation system (Recor Medical Inc, Otsuka Medical Devices Co Ltd) for the treatment of hypertension, as reported by Medscape Medical News.
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