Initial participant engages in Medtronic's multi-organ SPYRAL GEMINI Preliminary Trial
A pioneering study, known as the SPYRAL GEMINI Pilot, has been initiated to evaluate the safety and potential efficacy of a novel approach to managing uncontrolled hypertension. This landmark trial, conducted across multiple centres internationally, will investigate the feasibility of multi-organ denervation (MDN) using Medtronic’s Symplicity Spyral catheter.
The SPYRAL GEMINI Pilot study is designed to enrol up to 175 patients from the United States, Europe, and Australia. Participants will be divided into two parallel cohorts: those who are currently off antihypertensive medications (OFF MED) and those who are on medications (ON MED), with a high cardiovascular risk.
The primary objective of this exploratory study is to determine whether MDN, targeting both the renal and hepatic arteries, is feasible and safe, and to gather preliminary data on blood pressure reduction in this population. Procedural safety and efficacy will be assessed starting at three months post-procedure and followed through 36 months to monitor long-term outcomes.
Denervation of the renal arteries has previously demonstrated benefits in terms of blood pressure lowering, while hepatic artery denervation is an emerging area under clinical investigation. The hepatic artery, richly innervated, is believed to contribute to blood pressure regulation, making it an intriguing target for this innovative treatment approach. However, it is important to note that the hepatic artery denervation aspect is investigational and not approved for general use in any country; it is conducted strictly under clinical trial conditions.
The first patient in the programme was treated recently by Dr. Barry Bertolet at Cardiology Associates of North Mississippi and North Mississippi Medical Center in Tupelo, Mississippi. The study aims to generate hypotheses on the additional value of multi-organ (renal plus hepatic) denervation in managing hypertension, particularly in patients with high cardiovascular risk.
Preclinical data for the SPYRAL system has shown a 90% significant reduction in norepinephrine (a marker of sympathetic activity) with multiorgan denervation. Medtronic, the company behind the Symplicity Spyral system, is committed to investing in strategically important areas that hold promise for patients and the medical community.
In summary, the SPYRAL GEMINI Pilot study is paving the way for a multi-organ denervation strategy to potentially improve blood pressure control in patients with difficult-to-treat hypertension by simultaneously targeting both the renal and hepatic arteries using the Symplicity Spyral system. This groundbreaking research could offer new hope for those struggling to manage their hypertension effectively.
Digital health innovations are being explored in the SPYRAL GEMINI Pilot study, a clinical trial aimed at investigating the feasibility and safety of multi-organ denervation (MDN) using Medtronic’s Symplicity Spyral catheter. The study, focused on managing uncontrolled hypertension, will gather preliminary data on health-and-wellness outcomes, specifically blood pressure reduction, to contribute to science and medical-conditions research. Procedures and data collection will span over 36 months, with the primary objective being to determine the safety and efficacy of MDN, targeting both the renal and hepatic arteries.
