Medtronic Initiates Japanese Trial of Symplicity Renal Denervation System

October 1, 2012—Medtronic, Inc., (Minneapolis, MN) announced the start of Symplicity HTN-Japan. The clinical trial will assess the company's Symplicity renal denervation system in Japan for patients with treatment-resistant hypertension.

According to Medtronic, Symplicity HTN-Japan is an open-label clinical trial that will randomize subjects 1:1 to renal denervation versus no denervation with both groups receiving maximal tolerated doses of antihypertensive medications. The clinical trial is being conducted in approximately 100 patients across 11 centers in Japan. Kazuyuki Shimada, MD, former president of the Japanese Society of Hypertension, is the principal investigator of the study.

“Persistent hypertension may increase the risk of stroke and cardiovascular events,” commented Dr. Shimada in the company's announcement. “This trial to confirm the efficacy of renal denervation in Japanese patients with the Medtronic renal denervation system may be the first step toward a positive future for patients with treatment-resistant hypertension, which can be difficult to treat with conventional blood pressure medications. If the results of the trial are positive, it may have a marked impact on the current strategies for treatment-resistant hypertension, for which effective approaches have not yet been established.”

Medtronic stated that the Symplicity system consists of a flexible catheter and proprietary generator. The catheter is inserted into the femoral artery and threaded it into the renal artery. The Symplicity generator is then activated to deliver a controlled, low-power radio-frequency energy routine determined by Medtronic's algorithm to deactivate the surrounding renal nerves, thereby reducing hyperactivation of the sympathetic nervous system.

The company advised that the Symplicity renal denervation system was launched commercially in April 2010 and is currently available in parts of Europe, Asia, Africa, Australia, and the Americas. The device is not approved by the US Food and Drug Administration (FDA) and is not available for commercial distribution in the United States or Japan. In April 2011, the FDA approved the protocol for SYMPLICITY HTN-3, the company's clinical trial of the Symplicity system in the United States. More information is available on the Medtronic's Web site for the trial: http://www.symplifybptrial.com/.