The Clinical Benefit After Radiofrequency Renal Denervation: Pooled 36-Month Results From the Spyral Clinical Program

Objective: Hypertension is the leading modifiable risk factor for cardiovascular (CV) events world-wide. Lowering blood pressure (BP) reduces the risk of CV events and mortality. Renal denervation (RDN) is recommended by multiple societal guidelines for the treatment of hypertension. Across four clinical studies, over 2,000 patients have undergone radiofrequency (RF)-RDN using the Spyral RDN device (Medtronic Plc). We leveraged this pooled data set to evaluate long-term BP changes after RF-RDN and determined the proportion of patients who experienced a clinical benefit. Design and method: Data were pooled from the Global SYMPLICITY Registry (GSR) DEFINE, SPYRAL First-In-Human, SPYRAL HTN-OFF MED, and -ON MED trials. Office and 24-h ambulatory BP, medication, and safety outcomes were evaluated through 36 months. To determine the proportion of patients who experienced a clinical benefit, we considered Spyral patients with uncontrolled BP (office systolic [OS]BP >=140 mmHg) at baseline. Results: As of September 2025, 2,137 patients underwent RF-RDN with the Spyral device. At baseline, patients were 58±13 yrs old, 38.8% female, 29.9% had diabetes, 22.0% had chronic kidney disease. Baseline OSBP was 163±23 mmHg, and baseline 24-h ambulatory systolic (AS)BP was 152±17 mmHg. The number of antihypertensive (AH) medications was 3.8 ± 2.1 at baseline and 3.5 ± 1.9 by 36 months. At 36 months, there were significant reductions in BP (OSBP: -18.1±23.4 mmHg; ASBP: -13.3±17.6 mmHg; office diastolic BP: -8.1±13.9 mmHg; 24-h diastolic BP: -8.7±10.6 mmHg; all p<0.001 compared with baseline). Rates of all cause death, cardiovascular death, myocardial infarction, and hospitalization for hypertension emergency were low, and procedural safety events and instances of renal artery stenosis were rare. By 36 months, the proportion of Spyral patients who experienced either an OSBP reduction >=10 mmHg, an ASBP reduction >=5 mmHg, or a reduction of >=1 AH medication was 87.6%. Conclusions: In this pooled RDN cohort of patients treated using the Spyral device, there were significant and consistent BP reductions through 36 months with few adverse events. Nine in ten patients experienced a clinical benefit after RDN. These findings underscore the durability and safety of RF-RDN across a broad population of hypertensive patients.