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October 2, 2012- Wayne State University and Detroit Medical Center Cardiovascular Institute will participate in landmark study of novel approach to treat challenging hypertension

Detroit Medical Center Cardiovascular Institute today announced that it is now enrolling patients to participate in the SYMPLICITY HTN-3 study, a clinical trial of the investigational Symplicity® renal denervation system for treatment-resistant hypertension.* Treatment-resistant hypertension, defined as systolic blood pressure that remains high (greater than 140/90 mmHg) despite treatment with three or more antihypertensive medications, poses a serious health threat to nearly six million Americans and 100 million people worldwide.,

Treatment-resistant hypertension is an especially dangerous chronic disease because of its association with increased cardiovascular risk, including stroke and heart attack, as well as heart failure and kidney disease. Research suggests that 28 percent of treated hypertensive individuals are considered resistant to treatment. Additionally, these patients have a threefold increase in the risk of cardiovascular events compared with individuals with controlled high blood pressure.

Renal denervation is a minimally invasive, catheter-based procedure that regulates the output of nerves that line the walls of the arteries leading to the kidneys. These nerves are part of the sympathetic nervous system, which is one of the ways the body controls blood pressure. In people with hypertension, the renal nerves are hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.

"We’re excited to participate in the SYMPLICITY HTN-3 study of this investigational interventional treatment, which may represent a new and innovative approach to treating the growing number of resistant hypertension patients in the United States," said Theodore Schreiber, MD, President, DMC Cardiovascular Institute, Specialist-in-Chief, Cardiovascular Medicine, Harper University Hospital/Detroit Medical Center, Division Chief, Clinical Cardiology. "Renal denervation and ongoing treatment with antihypertensive medications have the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels."

SYMPLICITY HTN-3 is a randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg. The study will enroll approximately 530 treatment-resistant hypertension patients across several US medical centers. People receiving the investigational treatment will be compared with a control group that does not, with all patients continuing to take their blood pressure medications. Patients enrolled in the SYMPLICITY HTN-3 trial will be randomly assigned to a group, with two out of three assigned to the treatment group and one out of three assigned to the control group. In addition, those in the control group may receive the treatment after a six-month period passes. The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events.

"This study has a unique design since patients in the control group may have the option to receive renal denervation treatment six months following randomization, which may help extend the potential benefit of renal denervation to all participants in the trial if the trial demonstrates benefit," said John M. Flack, MD, MPH, Professor of Medicine and Physiology, Chair, Department of Medicine, Chief, Division of Translational Research and Clinical Epidemiology.

About the Symplicity Renal Denervation System
The Symplicity renal denervation system consists of a flexible catheter and proprietary generator. The Symplicity® catheter is introduced through a separate catheter placed through the skin into the femoral artery, located in the upper thigh, and is then threaded up into the renal artery leading to each kidney. It is connected to the Symplicity® generator, which produces controlled, low-power radio-frequency (RF) energy.

Once in place within the renal artery, the tip of the Symplicity catheter is placed against the arterial wall in several places where it uses controlled, low-power RF energy to deactivate the renal nerves according to a proprietary, computer-controlled algorithm. The treatment does not involve a permanent implant and is performed under conscious sedation.

The Symplicity renal denervation system has been successfully used since 2007 to treat more than 2000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity renal denervation system is not approved by the US Food and Drug Administration (FDA) for commercial distribution in the USA.

 


Patients can contact Donna Ford at 1-888-253-5467 or Elisabeta Levcovici at 313-993-0419 at Wayne State University for more information about the clinical trial.
People considering participation in the trial should be diagnosed with hypertension (high blood pressure) and unable to control their hypertension even when taking three or more blood pressure medications.

*Caution: Investigational device. Limited by United States law to investigational use.

Symplicity is a trademark of Medtronic, Inc. and is registered in one or more countries of the world.

© 2012 Medtronic, Inc. All rights reserved. Printed in USA.

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