Medtronic’s SPYRAL GEMINI Multiorgan Denervation Study Begins Enrollment

July 7, 2025—Medtronic announced that the first patient has been treated in its SPYRAL GEMINI global pilot study, which will investigate the safety and potential efficacy of multiorgan denervation (MDN) in patients with uncontrolled hypertension (HTN).

According to the company, the SPYRAL GEMINI pilot program is intended to evaluate the feasibility of combined denervation of both the renal and common hepatic arteries with the company’s Symplicity Spyral catheter.

As summarized in Medtronic’s press release, the prospective, multicenter, international, feasibility study includes two parallel cohorts of high-cardiovascular-risk patients with HTN, including those who are off antihypertensive medications (“OFF MED” study) and those who are taking antihypertensive medications (“ON MED” study).

Denervation will occur in both the common hepatic and main renal arteries and branches using the Symplicity Spyral catheter. Procedural safety and efficacy will both be evaluated starting at 3 months and continuing through 36 months postprocedure, noted the company.

Medtronic advised that the SPYRAL GEMINI pilot program will enroll up to 175 patients in the United States, Europe, and Australia. The first patient in the trial was treated by Barry Bertolet, MD, at Cardiology Associates of North Mississippi and North Mississippi Medical Center in Tupelo, Mississippi.

At EuroPCR 2025, Felix Mahfoud, MD, et al presented preclinical data showing a 90% significant reduction in norepinephrine with MDN, suggesting that MDN using the Spyral system can successfully denervate within both the hepatic and renal arteries, stated Medtronic.

The lead Principal Investigator of the SPYRAL GEMINI pilot study is David Kandzari, MD, Chief of Piedmont Heart Institute and Cardiovascular Services in Atlanta, Georgia.

“In addition to denervation of the renal arteries (where the blood pressure–lowering clinical benefit has already been established through multiple rigorously designed clinical trials), targeting other richly innervated vascular areas such as the common hepatic artery is an emerging horizon for treating HTN,” commented Dr. Kandzari in Medtronic’s press release. “We look forward to learning more about the potential efficacy of denervation in both the liver and renal arteries from SPYRAL GEMINI.”

The company advised that hepatic denervation is limited by law to clinical investigation in all geographies; the generator and catheter used in the SPYRAL GEMINI pilot study for hepatic denervation are not approved for sale or use in the United States or any other country.