Medtronic's Minimally Invasive Device for Hypertension Treatment Receives FDA Approval

Saturday, November 18, 2023

Medtronic plc has secured approval from the United States Food and Drug Administration (FDA) for its Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, aimed at treating hypertension. The company is poised to initiate commercialization promptly. Hypertension, a major modifiable cause of heart attack, stroke, and mortality, disproportionately affects underserved U.S. populations, despite available medications and lifestyle interventions. The approval is a significant milestone for Medtronic and represents a breakthrough for both physicians and patients in the realm of hypertension treatment.

The Symplicity blood pressure procedure, an innovative and minimally invasive technique, utilizes radiofrequency energy to target overactive nerves near the kidneys contributing to high blood pressure. Administered through a single thin tube (catheter) inserted into the kidney artery under sedation, the procedure aims to mitigate nerve activity. Importantly, no implant is left behind after the tube is removed.

Patient preference and shared decision-making are crucial aspects of hypertension care plans, including the Symplicity blood pressure procedure. A patient preference study led by Medtronic revealed that roughly one-third of patients expressed a preference for an interventional treatment option with blood pressure reduction and associated risks similar to those of the Symplicity blood pressure procedure.

This FDA approval marks a transformative step in hypertension treatment, providing a complementary solution alongside medication and lifestyle changes. The Symplicity blood pressure procedure addresses a significant unmet need in hypertension care, particularly for patients actively seeking alternative approaches to effectively manage their blood pressure.


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