Home health remedies Medtronic starts trial with Symplicity Spyral renal denervation system

Medtronic starts trial with Symplicity Spyral renal denervation system

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Irish technology firm Medtronic has secured approval from the US Food and Drug Administration (FDA) to commence a clinical study for assessing the Symplicity Spyral renal denervation system.

The company has started Spyral HTN-ON Med trial of Symplicity Spyral renal denervation system with high blood pressure (hypertension) patients who are already prescribed anti-hypertension medications.

Symplicity Spyral system secured approval for commercial use in over 50 countries, and is limited to investigational use in the US, Japan, and Canada.

Symplicity Spyral’s randomized and sham-controlled study is part of the firm’s Spyral HTN-ON Med global clinical program, and is designed to assess a patient population compared to what physicians commonly encounter in daily practice.

Medtronic’s latest trial is based on the randomized sham-controlled Spyral HTN-ON Med pilot study, which demonstrated renal denervation with the Symplicity Spyral system.

The 80-patient pilot study has showed statistically significant and clinically relevant reductions in both office and 24-hour systolic blood pressure, said the company.

Symplicity Spyral renal denervation system will be used to carry out a minimally invasive and radio frequency (RF)-based procedure to regulate the activity of nerves that lead to and from the kidney.

The 80-patient pilot study has showed statistically significant and clinically relevant reductions in both office and 24-hour systolic blood pressure, said the company.

The ON MED Trial is a 2:1 randomized and sham-controlled study, which will randomize up to 340 patients at 55 centers in the US, Japan, Europe, Australia and Canada. Patients in the trial will be followed up to three years.

According to the company, the primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months and the primary efficacy endpoint is 24-hour ambulatory blood pressure at six month.

Subjects will be provided with a stable regimen of up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers.

Medtronic cardiac and vascular group’s coronary and renal denervation business general manager and vice president Dave Moeller said: “Medtronic is committed to building a robust global renal denervation clinical program with results from several randomized, 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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