Medtronic has announced that the treatment of the first patient in the SPYRAL GEMINI pilot programme.
The trial seeks investigate the feasibility of combined denervation of both the renal and common hepatic (liver) arteries with the Symplicity Spyral catheter, and includes both ‘off-med’ and ‘on-med’ studies.
The first patient was treated by Barry Bertolet at Cardiology Associates of North Mississippi and North Mississippi Medical Center in Tupelo (USA).
The planned global pilot study of renal and hepatic combined denervation will investigate the safety and potential efficacy of the multi-organ denervation approach in uncontrolled hypertension patients who are both on and off medications.
“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 hypertension,” said David Kandzari chief of Piedmont Heart Institute and Cardiovascular Services (Atlanta, USA) and lead principal investigator of the SPYRAL GEMINI pilot study. “We look forward to learning more about the potential efficacy of denervation in both the liver and renal arteries from SPYRAL GEMINI.”
The SPYRAL GEMINI pilot study is a prospective, multicentre, international, feasibility study in two parallel cohorts of hypertensive patients, including patients off anti-hypertensive medications and patients with high cardiovascular risk who are taking anti-hypertensive medications. The programme will enrol up to 175 patients in the USA, Europe and Australia. 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 three months and continuing through 36 months post-procedure.
“As a pioneer in renal denervation, Medtronic is uniquely positioned to explore the clinical potential of multi-organ denervation with Symplicity Spyral’s low profile and single catheter design, and intellectual property in this field,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular portfolio at Medtronic. “As a company, Medtronic is committed to investing in strategically important areas that hold promise for patients and the medical community.”
Recently presented at the 2025 EuroPCR congress (20–23 May, Paris, France), preclinical data showed a 90% significant reduction in norepinephrine (marker of sympathetic activity) with multiorgan denervation. These findings suggest that multiorgan denervation using the Spyral system can successfully denervate within both the hepatic and renal arteries.
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 USA or any other country.
