Medtronic has commenced a Japanese clinical trial of its minimally invasive renal denervation therapy to treat patients who are not responding to different types of anti-hypertensive medications, and are at risk of stroke.
In an endovascular procedure, the Symplicity renal denervation system's flexible catheter is inserted into patients' femoral artery in the upper thigh, while the generator delivers a controlled, low-power radio frequency to modulate and deactivate the surrounding renal nerves causing chronic hypertension.
The open-label Symplicity HTN-Japan clinical study, which has enrolled approximately 100 patients across 11 centres in Japan, will randomise subjects 1:1 to renal denervation vs no denervation, with both groups receiving maximum 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 said.
"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 coronary and renal denervation senior vice president and president Sean Salmon said with the initiation of the study, the company continues its commitment to partner with the global medical community to explore the use of renal denervation in different patient populations.
"The initiation of the Symplicity system clinical trial in Japan marks a pivotal milestone for the Symplicity clinical program and brings us one step closer to helping to address an unmet clinical need for people in Japan with treatment-resistant hypertension," Salmon said.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.