Medtronic has announced that it will start a trial with its Symplicity renal denervation system in patients with chronic heart failure. The Symplicity system, one of the most innovative approaches to treating hypertension in recent years, consists of a flexible catheter and proprietary generator, which are used during an endovascular procedure to denervate the renal arteries using low-power radio-frequency energy. This results in a reduction of hyper-activation of the sympathetic nervous system.
The main indication for the Symplicity is therapy-resistant hypertension, however Medtronic is looking into expanding indications for the device and the new trial (SYMPLICITY-HF) is designed to evaluate the safety and physiologic response to renal denervation in patients with chronic heart failure and renal impairment. It will include 40 adult subjects with chronic heart failure and renal impairment in Europe and Australia.
Increased sympathetic activity is thought to play an important role in these conditions, and current pharmaceutical management already includes blocking the renin-angiotensin-aldosterone system with ACE inhibitors and addressing the sympathetic nervous system with beta-blockers. Renal denervation allows the selective reduction of the kidney’s contribution to central sympathetic drive.
In addition to this trial, Medtronic also announced the launch of a global patient registry for the Symplicity, with the goal of evaluating real-world, long-term results of renal denervation in over 5,000 patients with a number of conditions associated with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, heart failure, insulin resistance, chronic kidney disease and sleep apnea.
The Symplicity catheter system has received CE Mark approval in Europe in early 2010 but remains investigational in the United States. A large U.S. clinical trial in patients with treatment-resistant hypertension is currently underway (SYMPLICITY HTN-3).
Press release: Medtronic Launches Two New Clinical Programs to Evaluate the Use of Symplicity Renal Denervation System Across Multiple Conditions…
Product page: Symplicity Catheter System…
Flashbacks: Ardian’s Hypertension Treatment Outperforms Traditional Medical Treatment in Clinical Trial; Medtronic Gets FDA Nod for Renal Denervation Trial
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