Medtronic has enrolled the first patient at the Prairie Heart Institute, St. John’s Hospital in Springfield, US, in the Symplicity HTN-3 clinical trial of the Symplicity Renal Denervation system for treatment-resistant hypertension.
The Symplicity Renal Denervation System comprises a proprietary generator and flexible catheter.
The catheter, inserted through the skin into the femoral artery, is connected to the generator, which produces low-power radio-frequency (RF) energy.
Renal denervation – a minimally invasive, catheter-based procedure – regulates the output of arterial nerves that lead to the kidneys.
The randomised controlled Symplicity HTN-3 trial will enroll 530 treatment-resistant hypertension patients to assess the safety and effectiveness of renal denervation with the Symplicity Renal Denervation System.
The primary endpoints of the study include the change in blood pressure from baseline to six months and incidence of major adverse events up to six months following randomisation.