Medical device company Medtronic plc (NYSE: MDT) announced on Monday new two-year data from the SPYRAL HTN-ON MED clinical trial, revealing that patients treated with the Symplicity Spyral renal denervation (RDN) system experienced significantly greater reductions in 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to those in the sham group.
Results were presented at the 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT). This two-year data aligns with previous findings, indicating sustained, clinically meaningful blood pressure reductions with Symplicity RDN.
Specifically, ABPM in the RDN group declined by -12.1 mmHg versus -7.0 mmHg in the sham group, while OSBP fell by -17.4 mmHg in the RDN group compared to -9.0 mmHg in the sham group. No renal artery stenosis exceeding 70% was observed in the Spyral group after two years.
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial evaluating RDN's effectiveness and safety in patients on up to three antihypertensive medications. Medtronic also plans to explore multi-organ denervation, targeting both renal and hepatic arteries, in the upcoming SPYRAL GEMINI pilot study for patients with uncontrolled hypertension on and off medications. Symplicity Spyral use in the hepatic artery remains investigational.
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