Medtronic announces FDA approval of minimally invasive device to treat hypertension
The Symplicity™ blood pressure procedure offers patients a new adjunct approach to lowering blood pressure
Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology
DUBLIN, Nov. 17, 2023 /PRNewswire(opens new window)/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.
Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low. These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.