Medtronic’s Symplicity Spyral RDN Evaluated at 2 Years in SPYRAL HTN-ON MED

October 28, 2024—Medtronic announced new long-term data from the SPYRAL HTN-ON MED clinical trial of the company’s Symplicity Spyral renal denervation (RDN) system.

The findings show that patients who received RDN treatment using the Symplicity Spyral device had significantly greater reductions in 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to sham patients at 2 years, stated the company.

The data were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to Medtronic, 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 antihypertensive medications.

After the 6-month primary endpoint assessment, the study continued to assess 24-hour ABPM and OSBP from baseline through yearly follow-ups.

As summarized in Medtronic’s press release, the 24-month study data showed significant group differences in 24-hour ABPM and OSBP in favor of RDN, despite significantly more medications detected in the sham group:

• ABPM was -12.1 mm Hg in the RDN group versus -7 mm Hg in the sham group (treatment difference: -5.7 mm Hg; P =.039).
• OSBP was -17.4 mm Hg in the RDN group versus -9 mm Hg in the sham group (treatment difference: -8.7 mm Hg; P = .0034).

Additionally, the study showed long-term safety with no confirmed renal artery stenosis > 70% in the Spyral group at 2 years.

The 2-year data are consistent with other long-term data for Symplicity RDN, demonstrating clinically meaningful, consistent, and sustained blood pressure reductions, stated the company.

The lead Principal Investigator of the SPYRAL HTN-ON MED trial is David Kandzari, MD, Chief of Piedmont Heart Institute and Cardiovascular Services in Atlanta, Georgia.

“These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency RDN as a treatment for uncontrolled hypertension,” commented Dr. Kandzari in Medtronic’s press release. “Importantly, at 2 years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed across the SPYRAL and Global Symplicity clinical programs.”

Also in the press release, Medtronic stated that it intends to investigate multiorgan—hepatic artery and renal artery—denervation with the Symplicity Spyral catheter in the planned SPYRAL GEMINI global pilot study. The study will investigate the safety and efficacy of the multiorgan ablation approach in uncontrolled hypertension patients who are both on and off medications. The utilization of Symplicity Spyral in the hepatic artery is investigational and not approved for use, advised the company.

The press release also announced that Medtronic will expand the GSR DEFINE clinical trial to sites in the United States. The trial is an extension of the Global SYMPLICITY registry and is a prospective, all-comer, observational study in 251 sites across 55 countries, including 3,000 patients from the GSR study and enrolling up to an additional 2,000 patients globally.

Symplicity Spyral RDN system is approved for commercial use in > 75 countries around the world; in Japan, it is currently limited to investigational use, stated Medtronic.