WASHINGTON (dpa-AFX) - Medtronic plc (MDT) announced compelling long-term data from the final report of its SPYRAL HTN-ON MED randomized clinical trial. The results demonstrated that patients treated with the Symplicity Spyral renal denervation (RDN) procedure experienced significantly greater reductions in blood pressure over a three-year period compared to those in the sham control group.
Specifically, patients who underwent RDN (N=206) showed marked improvements in both 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to sham patients (N=131), despite both groups maintaining similar medication regimens. These findings reinforce the durability and effectiveness of the RDN procedure in managing hypertension.
Importantly, no cases of renal artery stenosis exceeding 70% were observed in the RDN group throughout the three-year follow-up, underscoring the long-term safety profile of the Symplicity Spyral system.
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications. After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow ups. The Symplicity RDN system is approved for commercial use in nearly 80 countries around the world.
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