8/16/2012 9:54:09 AM
Symplicity® Renal Denervation System™ could potentially help the nearly 6 million Americans with treatment-resistant hypertension
(LANCASTER, PA, April 2012)—Lancaster General Health (LGH) is pleased to announce its participation in the SYMPLICITY HTN-3 or Symplicity® Renal Denervation System™ study, a national clinical trial of an innovative treatment for hypertension in people whose blood pressure remains extremely high despite taking three or more medications.
“We are very eager to participate in this groundbreaking study that has the potential to dramatically change how physicians can help the growing number of people whose blood pressure is not adequately controlled by other medical treatments,” said study investigator Rupal P. Dumasia, M.D., FACC, FSCAI, Section Chief, Interventional Cardiology, The Heart Group of Lancaster General Health.
Renal denervation is a minimally invasive procedure in which a tiny device or catheter is threaded into the renal arteries to “burn” and deactivate the nerves to the kidneys that are partly responsible for the way the body controls blood pressure. When overactive, these nerves can raise blood pressure and contribute to heart attacks or stroke.
According to the American Heart Association, 76 million Americans have blood pressure. Of those, an estimated six million get no relief from available drugs.
“Refractory hypertension is a chronic condition that poses a serious health threat to people worldwide and is especially dangerous because of its association with adverse events such as stroke and heart attack,” added Dr. Dumasia. “That’s why it’s critical for any individual with high blood pressure to keep it under control and follow up regularly with their treating physicians.”
LGH is one of 90 sites in the nation, and one of the few in Southeastern PA, that will enroll people between the ages of 18 and 80 with treatment-resistant hypertension and systolic blood pressure greater than 160 mmHg in the five-year SYMPLICITY HTN-3 study. The trial is coordinated by clinicians at Lancaster Heart and Stroke Foundation. In the study, individuals will be randomly assigned to one of two groups: one will continue the best available medical treatment and the other will combine the best available medical treatment with a procedure where participants will have the renal denervation procedure.
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. It is not yet approved by the US Food and Drug Administration (FDA) for commercial distribution in the United States.
Anyone interested in learning more about the study or to determine if they are a candidate can call 717-544-5951. Prospective participants also are encouraged to visit www.SymplifyBPtrial.com, to learn more about the Symplicity HTN-3 study and their potential eligibility for the trial.