Medtronic Symplicity Spyral RDN Studied in Pooled Analyses from SPYRAL HTN Program

March 11, 2026—New analyses from the SPYRAL HTN clinical study program presented at CRT 2026 reported long-term outcomes with the Symplicity Spyral radiofrequency (RF) renal denervation (RDN) system (Medtronic), including a pooled 3-year efficacy analysis, a study of hypertensive urgencies, and the design of the SPYRAL CARE real-world study.

The pooled 3-year efficacy analysis was presented at CRT 2026, the Cardiovascular Research Technologies annual meeting, and simultaneously published by David E. Kandzari, MD, et al in EuroIntervention.

According to Medtronic, this first pooled analysis aimed to determine the proportion of patients who experienced clinical benefit from treatment with the Symplicity Spyral RDN system. Data from 2,137 patients were pooled from four trials: GSR DEFINE, SPYRAL First-In-Man, SPYRAL HTN-OFF MED, and SPYRAL HTN-ON MED. The results demonstrated that approximately nine of 10 patients experienced a clinical benefit—reduction in 24-hr ambulatory systolic blood pressure (ABPM), reduction in office-based systolic blood pressure (OSBP), or reduction of at least one antihypertensive medication—at 3 years, reported the company.

As summarized in the company’s press release, the results showed that patients treated with the Spyral device had significant mean reductions in OSBP and ABPM at 3 years, with OSBP of –18.1 ± 23.4 mm Hg compared with baseline (P < .0001) and 24-hour ABPM of –13.3 ± 17.6 mm Hg compared with baseline (P < .0001).

Additionally, 88% of patients experienced either an OSBP reduction ≥ 10 mm Hg, a 24-h ABPM reduction ≥ 5 mm Hg, or a reduction of at least one antihypertensive medication at 3 years; the results demonstrated amplified BP reduction through 3 years with few adverse events, stated Medtronic.

Dr. Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services, serves as lead Principal Investigator of SPYRAL HTN-ON MED.

“These results represent an important milestone in advancing clinician understanding of the long-term impact of RF RDN for patients with uncontrolled hypertension,” commented Dr. Kandzari in Medtronic’s press release. “We’re seeing sustained BP reductions that get progressively better with time, without an increase in concomitant medication burden. The data also demonstrates the potential to reduce the number of hypertensive medications and simplify treatment protocols—an outcome that we know can make a meaningful difference for patients when it comes to treatment burden and their everyday life.”

Also at CRT, Medtronic presented a pooled analysis showing hypertensive urgencies for SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED trials.

The pooled analysis showed hypertensive urgencies were 42% lower after RF RDN with the Symplicity Spyral device at 2-year follow-up. In the study, the potential annual hypertensive urgency-related health care cost savings were approximately $199 million per year, indicating RF RDN may have potential to help significantly reduce hypertensive urgency-related health care costs in the United States. This pooled analysis included 703 patients, treated with RF RDN (n = 388) versus sham (n = 315). Hypertensive urgency was defined in the pooled cohort as an office systolic BP ≥ 180 mm Hg or office diastolic BP ≥ 120 mm Hg, with or without symptoms.

Finally, Medtronic presented the study design for SPYRAL CARE, an observational study of the Medicare population with uncontrolled hypertension designed to provide real-world evidence for RF RDN in this patient population.

The SPYRAL CARE study will analyze medical and prescription claims linked to electronic health records and evaluate changes in OSBP and major cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and death) up to 2 years. The study was approved by the Centers for Medicare & Medicaid Services after its final National Coverage Determination on RDN, which was announced in October 2025, advised Medtronic.