US-based medical technology company Medtronic has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA), seeking approval to initiate the study of its minimally invasive catheter-based renal denervation system.
Featuring a flexible catheter and proprietary generator, the Symplicity renal denervation system is used to treat uncontrolled hypertension in patients with systolic blood pressure between 140mm Hg - 160mm Hg, who have not responded to the treatment with three or more anti-hypertensive medications of different classes.
The proposed Symplicity HTN-4 study, if permitted by the FDA, will provide randomised 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.
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 Symplicity HTN-4 study, which forms part of the company's global renal denervation clinical programme, is based on the company's pivotal US Symplicity HTN-3 study, evaluating the renal denervation system for treatment-resistant hypertension with systolic blood pressure greater than 160mm Hg.
The current study, which the company says is the second randomised study in the US, will include the patient population matching 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's definition of resistant hypertension.
The company plans to commence patient enrolment for HTN-4 in the second half of 2013, pending regulatory approval.
The trial will include more than 250 patients already enroled in the Symplicity HTN-1 and Symplicity HTN-2 studies, 530 patients being enrolled in the Symplicity HTN-3 study, and 5,000 patients being enrolled in the global Symplicity registry, according to the company.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.