Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure.
The RDN system holds approval for commercial use in more than 75 countries. Medtronic received a landmark approval for the system in November 2023.
Outcomes from the SPYRAL HTN-ON MED showed subjects who underwent the RDN procedure had significantly greater reductions in 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to sham patients at two years. Investigators presented the findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.
Dr. David Kandzari, the study’s principal investigator called the findings “key” in informing the medical community of RDN’s long-term effectiveness.
“Medtronic is uniquely positioned to explore the blood pressure lowering potential of multi-organ denervation. This is supported by both its intellectual property and the Symplicity Spyral catheter design, which enables access and treatment of the common hepatic artery – a vascular target rich with sympathetic innervation – with the same single catheter,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “The promising preclinical data highlight the potential for interventional denervation in the liver to support additional blood pressure lowering effects of the procedure. This approach underscores our dedication to innovation for both patients and physicians.”
More about the Medtronic RDN study
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications. After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow ups.
Two-year data fell in line with other long-term data for Symplicity, Medtronic said. It demonstrated clinically meaningful, consistent and sustained blood pressure reductions.
At two years, the data showed significant group differences in 24-hour ABPM and OSBP in favor of RDN. This occurred despite significantly more medications detected in the sham group. Long-term safety also came in strong, with no confirmed renal artery stenosis greater than 70% in the Spyral group at two years.
Medtronic said it intends to investigate multi-organ (hepatic artery and renal artery) denervation with Symplicity Spyral. Its plans for the SPYRAL GEMINI pilot study to investigate the safety and efficacy of the multi-organ approach. The company plans to look at this in uncontrolled hypertension patients both on and off medications.
Additionally, the company plans to expand its GSR-DEFINE trial to the U.S. GSR-DEFINE, an extension of the global SYMPLICITY registry, evaluates Medtronic RDN in 251 sites across 55 countries. In addition to the 3,000 patients from the GSR study, Medtronic expects to enroll up to an additional 2,000 patients globally.
“This year at TCT, we are not only reinforcing the consistent, long-term effects of radiofrequency denervation, but we’re further demonstrating our commitment to evidence generation and innovation,” said Jason Fontana, PhD, general manager Renal Denervation, and vice president of Global Marketing for the Coronary and Renal Denervation business. “As the leader in interventional hypertension treatments, we are excited to extend the largest evidence platform available to U.S. physicians and their patients.”