Australia joins Medtronic trial in fight against resistant hypertension

Medtronic has launched an international clinical trial across Australia, the United States, and Europe to evaluate the feasibility of multi-organ denervation targeting both the hepatic and renal arteries using its Symplicity Spyral catheter system.

The SPYRAL GEMINI pilot study aims to assess the safety and potential efficacy of this innovative approach in adults with uncontrolled hypertension. These patients present with a baseline systolic blood pressure (SBP) between 150 mmHg and 180 mmHg and a diastolic blood pressure (DBP) of 90 mmHg or higher, whether or not they are on antihypertensive medications.

Resistant hypertension affects 10% to 20% of treated patients despite treatment with three or more classes of antihypertensive drugs. When pseudo-resistant hypertension is included, prevalence increases up to 30%.

“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 Dr David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL GEMINI pilot study.

Supporting this direction, preclinical data presented at EuroPCR 2025 revealed a 90% reduction in norepinephrine, a key marker of sympathetic nervous system activity, following multi-organ denervation with the Spyral system.

“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.

The new trial builds on results from the SPYRAL HTN-ON MED study, which examined the safety and efficacy of renal denervation alone. At the two-year mark, patients treated with renal denervation experienced significantly greater reductions in both ambulatory and office-based systolic blood pressure compared to those who underwent a sham procedure.

Ambulatory systolic blood pressure dropped by 12.1 mmHg in the renal denervation group versus 7 mmHg in the sham group (p=0.039). Office-based systolic pressure showed an even more marked difference: a reduction of 17.4 mmHg compared to 9 mmHg in the sham group (p=0.0034). Importantly, long-term safety was favourable, with no cases of confirmed renal artery stenosis greater than 70% observed in the Spyral group at two years.

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