Medtronic to Study Symplicity Renal Denervation System in Multiple Conditions

February 13, 2012—Medtronic, Inc. (Minneapolis, MN) announced the start of the Global SYMPLICITY Patient Registry and the SYMPLICITY-HF clinical initiatives to evaluate the real-world clinical use of the company's Symplicity renal denervation system across multiple conditions.

The prospective, open-label, SYMPLICITY Patient Registry will enroll a minimum of 5,000 patients at approximately 200 centers worldwide and will collect real-world long-term data on the use of the Symplicity system in patients with conditions associated with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, heart failure, insulin resistance, chronic kidney disease, and sleep apnea. With the data, the investigators will evaluate the procedural and long-term safety of renal denervation, as well as efficacy and clinical outcomes. 
 

“Having one comprehensive platform will allow researchers to efficiently and effectively collect robust clinical data and gain important insights into the effects of renal denervation in other disease processes where increased sympathetic tone is believed to be important,” commented Michael Böhm, MD, who is Co-Chair of the Global SYMPLICITY Registry and serves as President of the German Society for Cardiology. “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 designed to evaluate the safety and physiologic response to renal denervation with the Symplicity system in approximately 40 adult patients with chronic heart failure and renal impairment in Europe and Australia. Professor Henry Krum, PhD, and Dr. Böhm are the study's Principal Investigators.

“In heart failure, reduced cardiac output and renal function are associated with increased sympathetic activity, particularly in the heart and kidneys,” commented Prof. Krum. “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 characterized by hyperactive sympathetic nervous system drive.”



The Symplicity renal denervation system consists of a flexible catheter and generator that deliver a controlled, low-power radiofrequency energy routine according to an algorithm, aiming to deactivate the surrounding renal nerves. This is intended to reduce hyperactivation of the sympathetic nervous system, which is an established contributor to chronic hypertension, without requiring a permanent implant, Medtronic stated.
 

The company advised that the Symplicity renal denervation system is commercially available in Europe and Australia but is not approved in the United States. In August 2011, the US Food and Administration granted Medtronic approval to conduct the pivotal SYMPLICITY HTN-3 clinical trial of the device for treatment-resistant hypertension.