Office-based systolic blood (OSBP) is a key secondary endpoint of the SPYRAL HTN-ON MED clinical trial of the Symplicity Spyral RDN System
Medtronic said that the SPYRAL HTN-ON MED study of the Symplicity Spyral Renal Denervation (RDN) System in hypertensive patients has shown meaningful clinical benefits on par with other SPYRAL HTN renal denervation trials.
The company announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical study.
The trial met a key secondary endpoint by significantly reducing the office-based systolic blood pressure (OSBP) with the treatment by Symplicity Spyral RDN System, compared to the sham control group.
According to Medtronic, the trial also met its primary safety endpoint by showing a low incidence of procedure-related and clinical adverse events.
However, the primary endpoint of showing a statistically significant reduction in 24-hour systolic ambulatory systolic blood pressure (ABPM) was not met. A 51% probability of superiority for the RDN group was noted compared to those who underwent a sham control operation.
Medtronic said that the pre-specified Win Ratio secondary endpoint that combines reduction in blood pressure with a decrease in medication burden, showed significance in favour of RDN compared to a sham procedure.
Medtronic chief scientific, medical, and regulatory officer Laura Mauri said: “Renal denervation lowers blood pressure and requires less medication for patients with hypertension.
“It is also a safe procedure. In this study specifically, RDN met both the safety endpoint for this trial, as well as the overall safety endpoint across the SPYRAL HTN ON and OFF MED studies.”
SPYRAL HTN-ON MED is a randomised, sham-controlled trial that studied the blood pressure lowering effect and safety of RDN with the radiofrequency (RF)-based Symplicity Spyral RDN system in hypertensive patients.
The healthcare technology firm said that the trial enrolled 337 patients with uncontrolled hypertension at 42 sites across the US, Europe, Australia, Japan, and Canada. They were randomly grouped in a 2:1 ratio to RDN versus sham control.
Medtronic said that it has filed the final module of the Symplicity Spyral Premarket Approval (PMA) package to the US Food and Drug Administration (FDA) for review and approval.