Medtronic has initiated two clinical programmes, SYMPLICITY-HF and Global SYMPLICITY Patient Registry, to demonstrate the clinical use of the company's Symplicity™ renal denervation system across multiple conditions.
The Symplicity renal denervation system features a flexible catheter and proprietary generator, which are used to perform a procedure called renal denervation (RDN), a minimally invasive, catheter-based procedure that 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 (RF) energy to deactivate the surrounding renal nerves.
The multi-centre, prospective, open-label Global SYMPLICITY Patient Registry will include a minimum of 5,000 patients to track patients with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, heart failure, insulin resistance, chronic kidney disease, and sleep apnea.
The registry will collect comprehensive data investigating procedural and long-term safety, as well as efficacy and clinical outcomes of the Symplicity renal denervation system.
Michael Böhm, chairman of the Department of Internal Medicine at University of Saarland, Homburg/Saar, Germany, said: "The Global SYMPLICITY Registry will allow clinicians worldwide to benchmark procedural practices in diverse patient populations, as well as better understand acute and long-term clinical, quality of life, and cost-effectiveness outcomes."
SYMPLICITY-HF is a Phase II clinical study that will enrol around 40 adult subjects with chronic heart failure and renal impairment to assess the safety and physiologic response to renal denervation with the Symplicity system.
Henry Krum, director of cardiovascular research and education at Monash University, Victoria, Australia, said: "The SYMPLICITY-HF clinical trial will examine whether regulating sympathetic activity through renal denervation may also provide benefit in patients with both heart failure and renal insufficiency, two other conditions characterised by hyperactive sympathetic nervous system drive."
Medtronic Coronary & Renal Denervation senior vice president and president Sean Salmon said, "Data from the Global SYMPLICITY Registry and the SYMPLICITY-HF clinical trial will build upon the substantial renal denervation data Medtronic has generated in patients with treatment-resistant hypertension to date."
Image: Medtronic has commenced clinical trials to evaluate the company's Symplicity renal denervation system. Photo: Bobak Ha'Eri.