Medtronic Reveals 3-Year Blood Pressure Reductions with Symplicity Spyral

Medtronic announced long-term results from its final report of the SPYRAL HTN-ON-MED randomized clinical trial that showed patients treated with the Symplicity Spyral renal denervation (RDN) procedure had significantly greater reductions in blood pressure compared to sham patients through three years.

The results were presented at this week’s Transcatheter Cardiovascular Therapeutics (TCT) conference. David Kandzari, M.D., chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program said radiofrequency renal denervation with Symplicity continues to show a durable and clinically meaningful blood pressure-lowering effect.

“Through three years, sustained reductions in blood pressure were observed among subjects treated with the Symplicity Spyral RDN system, including those from the treatment arm and the approximately three quarters of patients from the control arm that were later treated with Symplicity,” Dr. Kandzari told the press.

At three years, patients undergoing RDN had significantly greater reductions in both 24-ambulatory systolic blood pressure (−14.0 mmHg in the RDN group vs. −9.3 mmHg in the sham group) and office-based systolic blood pressure (OSBP) (−18.5 mmHg in the RDN group vs. −11.7 mmHg in the sham group), compared to sham patients, despite similar medication burden.

No renal artery stenosis more than 70% was seen in the RDN group through three years.

“These results further underscore the consistent and durable effects of the Symplicity blood pressure procedure, with the most long-term data presented and published to date,” said Jason Weidman, senior vice president and president of Medtronic’s Coronary and Renal Denervation business. “With more than 5,000 patients studied and over 30,000 procedures performed globally, the Symplicity blood pressure procedure continues to set the standard in renal denervation by offering a safe, effective, and lasting option for patients whose blood pressure remains uncontrolled despite medications and lifestyle modifications, and who are interested in an interventional approach to control their blood pressure.”