Medtronic Enrolls First Patient in SPYRAL GEMINI Trial Evaluating Combined Renal and Hepatic Artery Denervation for Hypertension

Medtronic Announces First Patient Enrolled in SPYRAL GEMINI Clinical Study. This study exploresFeasibility of Symplicity Spyral in treating hypertension through combined renal artery and common hepatic artery denervation.

PI Evaluation

"Besides renal denervation – whose clinical benefits in lowering blood pressure have been established through multiple rigorously designed clinical trials – targeting other densely innervated vascular regions such as the common hepatic artery is emerging as a new frontier in hypertension treatment. We look forward to further understanding the potential efficacy of liver and renal denervation through the SPYRAL GEMINI study."

---David Kandzari Piedmont Heart Institute

Executive Evaluation

"As a pioneer in the field of renal denervation, Medtronic holds a unique position in exploring the clinical potential of multi-organ denervation, thanks to the low-profile design and single-catheter operation features of the Symplicity Spyral catheter, as well as its intellectual property advantages in this area. As a company, Medtronic is committed to investing in areas of strategic importance that hold promise for patients and the medical community."

---Jason Weidman  Senior Vice President and President of Coronary and Renal Denervation Businesses under Medtronic's Cardiovascular Division

Introduction to the SPYRAL GEMINI Study

SPYRAL GEMINI Pilot Study is a prospective, multicenter, international feasibility study with two parallel cohorts of hypertensive patients, including a group of patients who have discontinued antihypertensive medications and a group of patients taking antihypertensive drugs but with high cardiovascular risk. The project plans to recruit up to 175 patients in the United States, Europe, and Australia. The procedure will use the Symplicity Spyral system to perform denervation on the common hepatic artery, main renal artery, and its branches. Evaluation of the safety and efficacy of the procedure will begin at 3 months post-operation and continue until 36 months post-operation.

Preclinical Study Data

Medtronic inAt the EuroPCR 2025 conference, announcedPreclinical Study Data on Combined Renal and Hepatic Denervation. The study shows:Multi-organ denervation can significantly reduce norepinephrine (a marker of sympathetic activity) by 90%. These findings suggest that usingSymplicity SpyralPerforming multi-organ denervation can successfully achieve denervation effects within the hepatic artery and renal artery.

Hypertension

Hypertension is a disease with an extremely high incidence rate (affecting over 1.3 billion people globally, including more than 245 million patients in China alone) and is the leading risk factor for cardiovascular diseases, posing a serious threat to human health. Currently, the gold standard for hypertension treatment remains pharmacotherapy. Although medications can effectively control blood pressure, some patients develop drug resistance, significantly reducing the effectiveness of antihypertensive drugs.

To this end, Medtronic invented the RDN therapy, which was approved by the FDA for marketing in 2023.Symplicity Spyral ablates renal arteriesThe sympathetic nerve can effectively and continuously reduce patients' blood pressure. Of course, RDN is not a panacea, and its efficacy is not significant for some hypertensive patients.Therefore, some companies want to further reduce patients' blood pressure by ablating the sympathetic nerves of other organs and make the effect last for a long time. (PS:The sympathetic nerve is the transmission between the brain andInformation between organs, therebyControl the body's energy needs. ThereforeSympathetic NerveThroughPlays an important role in regulating metabolism. When the sympathetic nerve is overactive, it can lead to the development and progression of various metabolic diseases, including hypertension, type 2 diabetes, and fatty liver.）

Medtronic has also recognized some shortcomings of RDN, therefore inAfter the Symplicity Spyral is launched, it quickly expands to multiple organs.Sympathetic NerveThrough the ablation treatment for hypertension, Medtronic not only solidifies its leading position in the hypertension treatment field but also potentially plans to expand into areas such as diabetes and fatty liver disease.

Medtronic JoinsMultiple OrgansSympathetic NerveIn the field of ablation, it is expected to bring another peak in the cardiovascular field and even open up a new direction for the development of cardiovascular treatment in the next decade.