Medtronic has enrolled the first US patient for Symplicity HTN-3 trial of the Symplicity Renal Denervation System to treat resistant hypertension.
The renal denervation system comprises a flexible catheter which is placed into the femoral artery and a proprietary generator delivers radio frequency (RF) energy to the surrounding sympathetic nerves and thus treats resistant hypertension.
The controlled, randomized, trial is designed to assess the safety and effectiveness of the renal denervation system in patients with treatment-resistant hypertension.
The study will enroll 530 patients across 60 US medical centers.
The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events up to six months following randomization.
The company concludes that clinical research data demonstrates that renal denervation with the Symplicity Renal Denervation System may provide sustained reduction in blood pressure levels for many patients with treatment-resistant hypertension.