US FDA approve new study of Medtronic’s Spyral renal denervation system

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Spyral

The FDA have given Medtronic approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system in patients with hypertension who are already prescribed anti-hypertension medications. A press release states that the SPYRAL HTN-ON MED trial is the latest prospectively powered, randomised, sham-controlled study within the broader SPYRAL HTN global clinical programme, and that the study will evaluate a patient population comparable to what physicians typically encounter in daily practice—patients with uncontrolled blood pressure taking multiple antihypertensive medications.

The press release adds that the design of the ON MED trial builds on the randomised sham-controlled SPYRAL HTN-ON MED pilot study that was published in The Lancet earlier this year; this 80-patient pilot study demonstrated statistically significant and clinically relevant reductions in both office and 24-hour systolic blood pressure in patients who had uncontrolled hypertension despite receiving optimal medication. Notably, those blood pressure lowering effects were observed not only throughout the daytime, but also during the night time and early morning periods when myocardial infarction and stroke risk due to hypertension are highest, resulting in the observation that renal denervation is “always on”.

The ON MED trial is a 2:1 randomised, sham-controlled study and will randomise up to 340 patients at 55 centres in the USA, Japan, Europe, Australia and Canada. Patients will be followed out to three years. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months. The primary efficacy endpoint is 24-hour ambulatory blood pressure at six months. Patients will be prescribed a stable regimen of up to three antihypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers.

David Kandzari (Piedmont Heart Institute, Atlanta, USA), principal investigator and member of the SPYRAL HTN Global Clinical Program Executive Committee, says: “A broad range of patients have hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches. This trial will add yet another critical piece to the renal denervation evidence basis and is designed to build on the success of our pilot study, which showed a benefit for renal denervation in an on-med patient population.”

Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, comments: “Medtronic is committed to building a robust global renal denervation clinical program with results from several randomised, sham-controlled, prospectively-powered, blinded clinical studies, in both the absence and presence of prescribed medications. Results from the ON MED trial will add to the growing body of evidence supporting renal denervation and is intended to support clinicians in making treatment decisions for patients who might benefit from this procedure.”

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