Medtronic’s landmark trial shows superiority for renal denervation in patients with high blood pressure

MedTech News: Medtronic announced first-ever clinical data from the SPYRAL HTN-OFF MED Pivotal Trial. The trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.

The study met its primary and secondary effectiveness endpoints, with a >99.9% probability of superiority for both versus those who received a sham control procedure (control arm). Additionally, there were no major device or procedural safety events through three months.

The study was presented on 30th March as part of the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions (ACC.20/WCC) and published simultaneously in The Lancet.

The global, sham-controlled study evaluated 331 patients—166 of whom were randomised to renal denervation (RDN), a minimally invasive procedure intended to regulate overactivity of nerves that lead to and from the kidney.

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Results showed a statistically significant 9.2 mm Hg reduction in patients’ office systolic blood pressure (OSBP) and 4.7 mm Hg reduction in 24-hour systolic ambulatory blood pressure (ABPM) at three months in those treated with the Symplicity Spyral RDN system.

A Victorian grandmother was the first patient in the world to receive renal denervation in 2007, under the care of Professor Murray Esler, a clinical cardiologist and medical scientist, based at the Baker Heart and Diabetes Institute and the Alfred Hospital in Melbourne.

“These results demonstrated outstanding safety, with zero procedural and device major adverse events through three months, and no worsening of kidney function. In previous research, blood pressure reduction of the magnitude observed here has been associated with a 20% reduction in relative risk of cardiovascular events,” Professor Esler said. “It is anticipated that the blood pressure lowering and safety demonstrated in this pivot trial will now lead to greater world-wide use of RDN in the treatment of hypertension, including in Australia.”

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“As many patients with uncontrolled hypertension struggle to adhere to lifelong drug therapy for a variety of reasons and may look to other options that complement traditional treatments, we believe this advance could help clinicians work with patients to better manage their high blood pressure,” said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business at Medtronic.

High blood pressure is the most common of all the conditions of the circulatory system. One in four Australians have hypertension, with around 4 million adults had uncontrolled or unmanaged high blood pressure (not taking medication).

The annual direct costs of hypertension are estimated at approximately AU$694 billion worldwide. It is estimated that almost 20 percent of patients with uncontrolled hypertension are completely non-adherent to oral medications, while nearly half are partially non-adherent, highlighting the need for alternative treatment options.

The Symplicity Spyral system is approved for commercial use in more than 60 countries around the world including Australia and New Zealand.

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