Medtronic has received approval from the US Food and Drug Administration (FDA) to study its Symplicity Spyral renal denervation system in a clinical trial for hypertension patients.
The randomised, sham-controlled SPYRAL HTN-ON MED Trial will enrol 340 patients suffering from uncontrolled blood pressure and are already using anti-hypertension medications.
Symplicity Spyral is a minimally invasive, radio frequency (RF)-based procedure designed to control the activity of nerves that lead to and from the kidney. It is expected to help manage blood pressure in patients taking anti-hypertensive drugs.
To be conducted at 55 centres in the US, Japan, Europe, Australia and Canada, the ON MED trial will involve a follow-up period of three years.
Primary safety endpoints of the study are set to include major adverse events at one month and new renal artery stenosis at six months.
It will also assess the primary efficacy endpoint of 24-hour ambulatory blood pressure at six months.
Medtronic Coronary and Renal Denervation business vice-president and general manager Dave Moeller said: “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.”
ON MED builds on a previous pilot study that showed statistically significant and clinically relevant decrease in office as well as 24-hour systolic blood pressure with Symplicity Spyral. These reductions were found to be consistent at different times of the day.
Medtronic is also conducting the SPYRAL HTN Pivotal Trial to investigate the renal denervation system in patients who are not using medications.