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Medtronic starts US trial of Symplicity renal denervation system for treatment-resistant hypertension
23 May 2013 - Medical technology company Medtronic Inc (NYSE:MDT) said today that it has completed patient enrolment for the US clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension.

The study, named Symplicity HTN-3, is Medtronic's first blinded, randomised, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension in the US. A total of 530 patients are taking part across nearly 90 medical centres, receiving either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone.

According to Medtronic the primary endpoints of the study are the change in blood pressure from baseline to six months following randomisation and the incidence of major adverse events one month following randomisation and renal artery stenosis to six months.

Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure. At present the Symplicity renal denervation system is available in more than 70 countries worldwide but it is only available for investigational use in the US and Japan.

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