SPYRAL HTN-ON MED trial demonstrates long-term improvements in patients
SPYRAL HTN-ON MED trial demonstrates long-term improvements in patients using Symplicity Spyral Renal Denervation System for hypertension.- Medtronic
Medtronic announced long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial which demonstrated that patients who were prescribed anti-hypertensive medications and treated with the Symplicity Spyral Renal Denervation (RDN) System continued to show durable, clinically significant blood pressure reductions through three years.
At three years there was 18.7 mmHg reduction in RDN patients versus 8.6 mmHg in sham for 24-hour systolic ambulatory blood pressure (ABPM), and 20.9 mmHg reduction in RDN patients versus 12.5 mmHg in the sham arm for office systolic blood pressure (OSBP).
Consistent blood pressure reductions have been observed in patients with uncontrolled hypertension treated with the Medtronic Symplicity Spyral RDN system. This randomized data demonstrates that in a typical patient population – hypertension patients who are on anti-hypertensive medications and treated with RDN – there are continued, long-term blood pressure lowering effect. Lowering blood pressure can have meaningful clinical results for patients, including a decrease in the risk of cardiovascular events.
The trial also demonstrated procedural and long-term safety with the Symplicity Spyral renal denervation catheter, with zero major device or procedural safety events through three years. The data were presented at the American College of Cardiology's 71st Annual Scientific Session (ACC.22) late-breaking featured clinical research sessions. The data were also simultaneously published in The Lancet.
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