Medtronic has begun its minimally invasive Symplicity renal denervation system's clinical trial in Japan to treat patients who are not responding to different types of anti-hypertensive medications and are at risk of stroke.
The system features a flexible catheter which is inserted into patients' femoral artery in the upper thigh as well as a generator that delivers a controlled, low-power radio-frequency energy to modulate and deactivate the surrounding renal nerves causing chronic hypertension.
The open-label Symplicity HTN-Japan clinical study, which is being conducted in approximately 100 patients across 11 centers in Japan, will randomize subjects 1:1 to renal denervation vs. no denervation with both groups receiving maximal tolerated doses of anti-hypertensive medications.
Japanese Society of Hypertension former president and clinical trial principal investigator Dr. Kazuyuki Shimada said persistent hypertension may increase the risk of stroke and cardiovascular events.
"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," Shimada added.
"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."
