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Medtronic said Thursday that a pivotal US trial of its Symplicity renal denervation system for treatment-resistant hypertension failed to meet its main efficacy endpoint. The company noted that based on the results of the SYMPLICITY HTN-3 study, it will form an independent panel "to make recommendations about the future of the global hypertension clinical trial programme, as well as provide advice on continued...access to the Symplicity technology in countries with regulatory approvals."
Depending on the panel review, the company said that it plans to suspend enrollment in the three countries where renal denervation hypertension studies are under way, including, the SYMPLICITY HTN-4 trial in the US, the HTN-Japan study in Japan and the HTN-India trial in India. Chief medical officer Rick Kuntz remarked that "we believe this course of action…will help us thoroughly evaluate these findings and determine the appropriate next steps for renal denervation therapy."
The Symplicity system received CE mark approval in 2008, with Medtronic announcing last month that regulators in Europe and Australia cleared the Symplicity Spyral catheter and Symplicity G3 radio frequency generator. The device maker said Thursday that it is evaluating the value of its renal denervation assets and believes "a one-time impairment charge in the future will be likely," but reiterated its revenue outlook and diluted earnings per share guidance for fiscal 2014.
The SYMPLICITY HTN-3 trial randomised 535 patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg to a treatment or a control group, with all participants continuing to take blood pressure medications. The primary endpoints of the study were the change in office blood pressure from baseline to six months and incidence of major adverse events. Co-principal investigator Deepak L. Bhatt noted that the study "met its primary safety endpoint related to the incidence of major adverse events one month following randomisation and renal artery stenosis to six months."
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