Medtronic has announced the start of Symplicity HTN-Japan, the first clinical trial with the Symplicity renal denervation system in Japan for patients with treatment-resistant hypertension.
The clinical trial is an open-label study that will randomise subjects 1:1 to renal denervation vs. no denervation with both groups receiving maximal tolerated doses of antihypertensive medications. The clinical trial is being conducted in approximately 100 patients across 11 centres in Japan.
“Persistent hypertension may increase the risk of stroke and cardiovascular events,” said Kazuyuki Shimada, the former president of the Japanese Society of Hypertension, and principal investigator of the clinical trial. “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.”
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 Symplicity renal denervation system is not approved by the FDA for commercial distribution in the United States or Japan.