Medtronic has submitted its investigational device exemption (IDE) application to the FDA to initiate a study of its Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg.
The study, Symplicity HTN-4, is based on the company's pivotal US Symplicity HTN-3 trial evaluating the renal denervation system for the treatment-resistant hypertension with systolic blood pressure greater than 160 mm Hg.
The study, which the company claims to be the second randomized study in the US, will include the patient population in line with the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-7), the American Heart Association and the European Society of Hypertension definition of resistant hypertension.
The proposed study, if permitted by the FDA, will provide randomized safety and efficacy data for renal denervation in various patients, as well as help increase understanding of the potential benefit of renal denervation on patients with a less severe form of treatment-resistant hypertension, according to the company.
Medtronic coronary and renal denervation senior vice president and president Sean Salmon said, "We intend to continue to add to the substantial body of evidence Medtronic has generated to support the use of renal denervation in broader patient populations worldwide in conditions associated with hyperactive sympathetic nervous system drive, including uncontrolled and treatment-resistant hypertension, and heart failure."
The company plans to commence patient enrollment for the Symplicity HTN-4 study in the second half of 2013, pending regulatory approval.
