Patient received initial treatment in Medtronic's multi-organ SPYRAL GEMINI trial experiment
In a significant stride towards addressing uncontrolled hypertension, Medtronic has initiated the SPYRAL GEMINI Pilot study, an international, prospective, multicenter feasibility trial [1][2][3]. This innovative study aims to evaluate the safety and potential efficacy of multi-organ denervation (MDN) in patients with hypertension, both on and off antihypertensive medications.
The main objective of the SPYRAL GEMINI Pilot study is to assess the feasibility of combined denervation of two richly innervated vascular areas: the renal arteries and the common hepatic artery (liver) [1][2][3]. Medtronic’s Symplicity Spyral catheter will be used for this purpose.
The study enrolls up to 175 hypertensive patients across the United States, Europe, and Australia, including those with high cardiovascular risk [2]. Patients are studied in two parallel cohorts: those off medications ("OFF MED") and those on medications ("ON MED") [1][2].
The study will assess procedural safety and efficacy, with follow-up evaluations beginning at 3 months and continuing through 36 months post-procedure [2]. While renal artery denervation has an established blood-pressure-lowering benefit from prior rigorous trials, targeting additional sites like the hepatic artery is an emerging approach aimed at improving treatment outcomes for hypertension [1][3].
Dr. David Kandzari, the lead principal investigator, highlighted the innovation of adding hepatic artery denervation to renal denervation to explore its potential efficacy in managing hypertension [1][3].
Preclinical data presented at EuroPCR 2025 demonstrated a 90% significant reduction in norepinephrine with multiorgan denervation using the Spyral system, further supporting the potential benefits of this approach [4]. The Spyral system was found to successfully denervate within both the hepatic and renal arteries.
However, it's important to note that the hepatic denervation component is currently limited by law to clinical investigation only, and the devices used for hepatic artery denervation are not yet approved for widespread clinical use [1].
In summary, the SPYRAL GEMINI Pilot study seeks to provide initial data on whether combined renal and hepatic artery denervation can be a safe and effective treatment approach to reduce blood pressure in patients with uncontrolled hypertension, potentially expanding the therapeutic options beyond renal denervation alone [1][2][4]. Medtronic's commitment to investing in strategically important areas that hold promise for patients and the medical community underscores their dedication to advancing healthcare.
- The SPYRAL GEMINI Pilot study, a clinical trial conducted by Medtronic, is focused on assessing the feasibility of a new treatment approach for hypertension: multi-organ denervation, which involves denervating the renal arteries and the common hepatic artery (liver) using the Symplicity Spyral catheter.
- This innovative study also aims to evaluate the potential benefits of combining renal artery denervation, a method with established blood-pressure-lowering effects, with denervation of additional sites like the hepatic artery for improved hypertension treatment outcomes.
- The study's findings could expand the therapeutic options for managing uncontrolled hypertension, particularly in the field of digital health, and contribute significantly to the advancement of science in health-and-wellness, cardiovascular-health, and medical-conditions.
