Medtronic Starts Trial with Symplicity Renal Denervation System for Chronic Heart Failure and Renal Impairment

Medtronic Starts Trial with Symplicity Renal Denervation System for Chronic Heart Failure and Renal Impairment

Mountain View, CA based Ardian Inc. has announced the results of a six month study which evaluated the company’s Symplicity Catheter System for treatment of chronic drug resistant hypertension. The study compared the outcomes of patients taking three or more antihypertensive drugs to those treated with the Symplicity. The results of the study, reported in the Lancet, demonstrated that a six month treatment with Ardian’s technology proved more effective than traditional medical treatment in patients with sustained grade 2 hypertension (baseline SBP of 160 mm Hg or more). The Symplicity System is a catheter-based low-power radiofrequency (RF) renal denervation device, thought to permanently treat hypertension by reducing or eliminating the sympathetic innervation of the renal arteries, hence “reducing both the pathologic central sympathetic drive to the kidney and the renal contribution to central sympathetic hyperactivity.”

More from the press release:

q4gwr Ardians Hypertension Treatment Outperforms Traditional Medical Treatment in Clinical Trial

The Symplicity HTN-2 trial was an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. One hundred-six patients were enrolled from 24 investigational sites. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. After six months, the average blood pressure of the renal denervation group was reduced to 146/85 mmHg, compared to an average blood pressure of 179/98 mmHg for the control group.

The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

Symplicity™ Catheter:

The Symplicity Catheter is specifically designed for safe endovascular application in the renal artery. Key features include:

6F compatible

Ergonomic controls for rotation and articulation

Self-orienting tip for confident, atraumatic vessel wall contact

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.

Medtronic Symplicity device Medtronic Starts Trial with Symplicity Renal Denervation System for Chronic Heart Failure and Renal ImpairmentThe 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).

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