Galway, Ireland, and San Diego, California, USA, November 3, 2026
Medtronic plc, a global healthcare technology company, has announced positive six-month primary endpoint results from its SPYRAL AFFIRM post-approval study, demonstrating significant blood pressure reductions among patients treated with its Symplicity Spyral™ renal denervation (RDN) system. The findings were presented as late-breaking clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 Annual Meeting and simultaneously published in Circulation: Cardiovascular Interventions. The study evaluated the real-world performance of renal denervation technology in patients with uncontrolled hypertension, a condition associated with increased risks of heart attacks, strokes, kidney disease and other cardiovascular complications. At six months, patients treated with the Symplicity Spyral system experienced reductions in office, home and 24-hour ambulatory systolic blood pressure without an increase in antihypertensive medication use. According to Medtronic, nearly nine out of ten patients experienced a clinical benefit at six months. The announcement also included an important regulatory development, with the U.S. Food and Drug Administration (FDA) approving an updated product labeling for the Symplicity Spyral Multi-Electrode Renal Denervation Catheter. The updated labeling incorporates additional clinical evidence involving patients with isolated systolic hypertension, chronic kidney disease and type 2 diabetes, further expanding the clinical information available to healthcare professionals when considering hypertension treatment options.
SPYRAL AFFIRM Study Demonstrates Significant Blood Pressure Reduction
The SPYRAL AFFIRM study is a prospective, multicenter, single-arm post-approval investigation designed in collaboration with the U.S. FDA to evaluate the real-world performance and safety of the Symplicity Spyral renal denervation system. The research focuses on patients with uncontrolled hypertension receiving treatment across diverse clinical settings and patient populations. Its six-month primary endpoint results demonstrated statistically significant reductions across three important blood pressure measurements. Patients experienced an average reduction of 18.2 mmHg in office systolic blood pressure, with a standard deviation of 22.0 mmHg. Home blood pressure measurements decreased by an average of 9.4 mmHg, while 24-hour ambulatory blood pressure declined by 9.7 mmHg. All three reductions were statistically significant, with p-values below 0.0001. The study also reported similar blood pressure reductions among women, Black American and Hispanic patients, and individuals aged 65 years and older. Importantly, the average number of antihypertensive medications remained unchanged at 3.6 medications per patient through six months. The reported composite safety endpoint occurred in 2.1% of patients. These findings provide additional real-world clinical evidence regarding the potential role of renal denervation in managing hypertension that remains uncontrolled despite medication and lifestyle interventions.
Symplicity Spyral Technology Targets Renal Nerves
The Symplicity Spyral renal denervation system is an advanced catheter-based medical technology designed to help manage uncontrolled hypertension by targeting nerves surrounding the renal arteries. The procedure, known as renal denervation, uses radiofrequency energy delivered through a specialized multi-electrode catheter to disrupt selected renal sympathetic nerve pathways. These nerves play an important role in regulating blood pressure through their influence on kidney function, vascular resistance and the body’s sympathetic nervous system. By reducing excessive sympathetic nerve activity, renal denervation is intended to support blood pressure reduction alongside conventional treatments. The Symplicity Spyral system uses a multi-electrode catheter designed to deliver radiofrequency energy to multiple locations within the renal arteries. The minimally invasive procedure is performed by trained physicians in an appropriate clinical setting. It is intended to complement, rather than replace, lifestyle modifications and prescribed antihypertensive medications. According to the company, the SPYRAL AFFIRM findings demonstrate reductions in office, home and ambulatory blood pressure, providing evidence across different measurement settings. A separate pooled analysis cited by Medtronic also reported sustained clinical benefit at three years. These developments highlight continued research into device-based approaches for patients who experience difficulty achieving adequate blood pressure control through conventional treatment strategies.
Advertisement
FDA Labeling Update Expands Clinical Evidence for Treatment Decisions
Alongside the clinical study results, Medtronic received FDA approval for an updated U.S. labeling for its Symplicity Spyral Multi-Electrode Renal Denervation Catheter. The revised labeling incorporates additional clinical evidence from the SPYRAL HTN clinical programme, including SPYRAL AFFIRM and the Global SYMPLICITY Registry DEFINE. The updated information covers patients with isolated systolic hypertension (ISH), chronic kidney disease up to stage 3b with an estimated glomerular filtration rate of at least 30 mL/min/1.73 m², and type 2 diabetes. These patient populations represent important groups in hypertension management because elevated blood pressure frequently occurs alongside metabolic and kidney-related complications. The updated labeling provides physicians with additional clinical evidence to support discussions and treatment decisions for appropriate patients. However, Medtronic confirmed that the system’s existing indication for use remains unchanged. The Symplicity renal denervation system is approved for commercial use in more than 80 countries worldwide. Overall, the latest SPYRAL AFFIRM findings and FDA labeling update represent significant developments in cardiovascular medical technology, highlighting the growing importance of clinical research and minimally invasive treatment approaches for uncontrolled hypertension.
Source: Medtronic press release
