With global hypertension rates on the rise and treatment resistance becoming increasingly complex, Medtronic is breaking new ground through its SPYRAL GEMINI Pilot Study. By investigating the efficacy and safety of multiorgan denervation—targeting both the renal and hepatic arteries—the company aims to redefine device-based blood pressure control. In this exclusive interview, MedTech Spectrum speaks with Sandeep Brar, Vice President of Clinical and Regulatory for the Coronary and Renal Denervation operating unit at Medtronic, to explore the clinical rationale, catheter design, and implications for the future of hypertension care.
What clinical rationale and preclinical data informed the decision to target both the renal and hepatic arteries in the SPYRAL GEMINI Pilot Study?
Targeting other richly innervated vascular beds is an emerging horizon for treating hypertension to further enhance the significant RDN treatment effect and reduce its variability. Preliminary, recently presented preclinical data indicate that multiorgan denervation resulted in a 90% reduction in both renal and liver norepinephrine levels, with low variability observed. Medtronic is currently conducting research and development in areas relevant to both the company and the medical field.
How does the Symplicity Spyral™ catheter’s design enable safe and effective multi-organ denervation, and what key technical adaptations were made for hepatic application?
The SPYRAL GEMINI Pilot Study uses the existing Spyral catheter and an investigational generator system that is only approved for use in the study to explore new ablation targets, efficiently treating 3-8mm vessels with a single catheter capitalizing on the excellent deliverability and unique ability to treat unique vessels. The Gemini System is comprised of the Symplicity G3™ Renal Denervation RF Generator for renal denervation, the Symplicity G3™ Renal Denervation RF Generator modified with Gemini parameters for hepatic denervation and the Symplicity Spyral Catheter.
Can you elaborate on the patient selection criteria for the ‘OFF MED’ and ‘ON MED’ arms, and how the study is structured to evaluate efficacy across these cohorts?
The primary objectives of the SPYRAL GEMINI Pilot Study are to confirm safety and assess the efficacy of multiorgan denervation in various cohorts of uncontrolled hypertension patients, including those on and off medications. Key inclusion criteria include a baseline office systolic blood pressure of greater than 150 mmHg and less than 180 mmHg and office diastolic blood pressure of greater than 90 mmHg and a 24-hour average systolic blood pressure of greater than 140 mmHg and less than 170 mmHg.
What specific endpoints will the study monitor over the 36-month follow-up, and how might early safety and efficacy findings inform the future of device-based hypertension management?
The SPYRAL GEMINI Pilot Study is a prospective, multicenter, 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 Pilot Study will investigate and assess the vascular safety and change in office and ambulatory blood pressure in uncontrolled hypertension patients who are both on and off medications.
Given the global scope of the study, how does Medtronic envision scaling multi-organ denervation if clinical success is demonstrated—and what regulatory or adoption challenges do you foresee?
Medtronic remains committed to running a rigorous clinical program and following the science, and we intend to discuss commercial plans after completing the trial.
