The US FDA has approved Medtronics’ Investigational Device Exemption (IDE), which will allow the company to initiate Symplicity™ HTN-4, the first randomized trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in US patients.
Medtronic’s seemingly endless list of studies on Renal Denervation using the Symplicity device, is really trying to cover all the bases as the company aims to ensure its indications are as broad as possible when it finally gains approval to market. This new study plugs another gap. The first Symplicity Study, so called Symplicity HTN-1 investigated the impact of the therapy on patients with uncontrolled hypertension including systolic pressure of over 160mmHg. More recently the company’s HTN-3 pivotal study had the same inclusion criteria.
Symplicity HTN-4 will evaluate the system in patients with moderate uncontrolled hypertension, defined as systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite treatment with three or more anti-hypertensive medications of different classes.
Symplicity HTN-4, which enrolled its first patient at Duke University Medical Center, is Medtronic’s second randomized, controlled renal denervation clinical trial in the United States.
The Symplicity renal denervation system remains currently available only for investigational use in the United States.
“SYMPLICITY HTN-4 builds upon our rigorous clinical evaluation of the Symplicity renal denervation system designed to carefully and progressively develop the clinical evidence platform for the treatment of hypertension,” said Nina Goodheart, Vice President, General Manager, Renal Denervation, Medtronic. “We’re excited to initiate this study, even while patient follow-up continues in our pivotal U.S. clinical trial for patients with uncontrolled hypertension who have systolic blood pressure at or above 160. The SYMPLICITY HTN-4 trial will allow us to potentially extend the benefits of renal denervation to patients with more moderate uncontrolled hypertension in the United States.”
“This highly-anticipated, robust study will serve a key role in evaluating renal denervation in these underserved patients with less severe hypertension so that we’re able to understand what benefit this novel therapy may offer patients outside of the currently indicated patient population,” said Michael Weber, M.D., Co-Primary Investigator of SYMPLICITY HTN-4 and Professor of Medicine, Division of Cardiovascular Medicine, at the SUNY Downstate College of Medicine in Brooklyn, N.Y.
“Over the past several years, the Symplicity renal denervation system has successfully treated patients outside the U.S. with a more severe form of uncontrolled hypertension characterized by systolic blood pressures at or above 160 mm Hg,” explained David Kandzari, M.D., Co-Principal Investigator of SYMPLICITY HTN-4 and Chief Scientific Officer and Director of Interventional Cardiology, Piedmont Heart Institute, Atlanta, Ga. “However, many patients with uncontrolled hypertension have blood pressure between 140 and 160 mmHg, making this also a very important group to study, since we know the risk for cardiovascular mortality and morbidity increases linearly for every millimeter of systolic blood pressure elevation above 140.”
Full release, including details of all Symplicity studies, here.
Source: Medtronic, Inc.