Medtronic's Symplicity renal denervation system has demonstrated safe and sustained blood pressure reduction for up to three years in patients with treatment-resistant hypertension, according to the Symplicity HTN-1 and Symplicity HTN-2 trials.
Symplicity features a flexible catheter and proprietary generator, which are used to perform a procedure called renal denervation, a minimally invasive, catheter-based procedure which modulates the output of nerves that line the walls of the arteries leading to the kidneys.
The physician inserts the small, flexible catheter into the femoral artery in the upper thigh and once in place within the renal artery, the generator is activated to deliver a controlled, low-power radio-frequency energy to deactivate the surrounding renal nerves.
Symplicity HTN-1 is a series of pilot studies involving 153 patients who maintained an average blood pressure reduction of 33/19mm Hg at 36 months from baseline, following treatment with the Symplicity system.
The Symplicity HTN-2 trial is an international multicentre prospective randomised controlled study, designed to assess the safety and effectiveness of renal denervation in patients with treatment-resistant hypertension.
The 106-patient HTN-2 study showed that patients randomised to renal denervation achieved a mean blood pressure reduction of 32/12 mmHg following six months of treatment.
Baker IDI Heart and Diabetes Institute of Melbourne, Australia, associate director and principal investigator of the Symplicity HTN-2 trial Murray Esler said the results demonstrate that Symplicity has the potential to provide long-term safety and efficacy for patients who have been unable to achieve target blood pressure levels.
The Symplicity renal denervation system is not yet approved by the US Food and Drug Administration for commercial distribution in the US. Headquartered in Minneapolis, US, Medtronic offers medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Image: Medtronic World Headquarters, Fridley, Minnesota, US. Photo: Bobak Ha'Eri.