EMBRACE to Study Medtronic’s Symplicity Spyral RDN System With Staged PCI

March 31, 2026—Medtronic announced it is supporting the investigator-initiated EMBRACE trial of the company’s Symplicity Spyral renal denervation (RDN). Also, the company announced that data from a pooled analysis of the SPYRAL HTN ON- and -OFF MED trials for the Symplicity Spyral were presented at ACC.26, the American College of Cardiology’s annual scientific session.

According to company, the randomized, multicenter EMBRACE trial is evaluating the Symplicity Spyral RDN treatment added to staged percutaneous coronary intervention (PCI) versus staged PCI alone in patients with uncontrolled hypertension and multivessel coronary artery disease.

As noted in Medtronic’s press release, EMBRACE will enroll 1,000 patients with multivessel disease and uncontrolled hypertension undergoing staged PCI. The trial will be conducted across 55 sites in the United States, Europe, and Asia.

Medtronic advised that the primary endpoint will be assessed at 2 years, with a total follow-up extending to 3 years. Clinical effectiveness with radiofrequency RDN will be assessed using a composite endpoint that includes cardiovascular death, stroke, myocardial infarction, and hospitalization for heart failure or hypertensive crisis, among others.

The investigator-initiated trial is led by Roxana Mehran, MD, and Felix Mahfoud, MD, and funded by Medtronic, noted the company.

“PCI is no longer the end of the journey—it’s the beginning of a broader strategy to address residual cardiovascular risk,” commented Dr. Mehran in Medtronic’s press release. “Uncontrolled hypertension remains a key driver of recurrent events, and EMBRACE explores a potential ‘sweet spot’ where revascularization and RDN can be combined to move from intervention to prevention.”

The results from a pooled analysis of the SPYRAL HTN ON- and -OFF MED trials were presented by Professor Michael Böhm, MD. The pooled analysis of 388 patients randomized to RDN and 315 to sham control showed RDN patients had a significantly lower rate of hypertensive urgencies (40%) compared to sham control patients through 3 years.

As summarized in the company’s press release, the cumulative mean hypertensive urgency incidence at 3 years for RDN versus sham was 0.21 versus 0.39 per patient (hazard ratio, 0.60; 95% CI, 0.40, 0.90; P = .014). RDN patients also had a statistically significant lower medication burden compared to sham at 3 years (3.7 ± 4.3 vs 6.0 ± 11.2; P = .003). Finally, assuming an RDN treatment adoption rate of 50%, the potential hypertensive urgency-related health care costs savings in the United States was approximately $380 million per year, reported Medtronic.