UVM/Fletcher Allen Participates in Study of Novel Approach to Treat Challenging High Blood Pressure

F O R  R E L E A S E:
Immediate (July 16, 2012)


Jennifer Nachbur
UVM Communications
College of Medicine

Mike Noble
Marketing and Communications
Fletcher Allen Health Care


BURLINGTON, VTFletcher Allen Health Care today announced participation in a clinical trial to investigate a new procedure to care for patients with treatment-resistant high blood pressure. Treatment-resistant high blood pressure is a condition where systolic blood pressure remains high despite treatment with three or more high blood pressure medications. Systolic pressure is the force of blood in the arteries as the heart beats. This condition poses a serious health threat to nearly six million Americans.

The investigational procedure called renal denervation is a minimally invasive, catheter-based procedure that modifies the output of nerves that lie within the renal artery wall and lead into and out of the kidneys. These nerves are part of the body’s sympathetic nervous system, which is one of the ways the body controls blood pressure. In people with high blood pressure, or hypertension, the renal nerves are hyperactive and raise blood pressure, contributing to heart, kidney and blood vessel damage.

The renal denervation procedure is performed in a cardiac catheterization laboratory. A catheter is inserted into patient’s femoral artery in the upper leg and moved up to the renal artery.

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

UVM/Fletcher Allen Health Care is one of up to 90 sites in the United States selected to participate this trial, which uses a renal denervation system made by Medtronic, called Symplicity. The trial will determine the safety and efficacy of this new type of treatment. The team participating in this trial comprises staff from both the Cardiology and Nephrology departments.

“We’re excited to participate in the 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 Harry Dauerman, M.D., UVM professor of Medicine and director of the Cardiac Catheterization Laboratory at Fletcher Allen.  “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.”

For more information about the Medtronic SYMPLICITY HTN-3 U.S. Clinical Trial, see www.SymplifyBPtrial.com.

For more information on the trial at Fletcher Allen, click here.

About the Medtronic 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 energy.

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 Richard Solomon, M.D., UVM professor of Medicine and chief of Nephrology at 802-847-3572 at Fletcher Allen Health Care, Burlington, VT, for more information about the clinical trial. 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. 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.

About Fletcher Allen
Fletcher Allen Health Care, together with our partners at the University of Vermont College of Medicine and the College of Nursing and Health Sciences, is Vermont’s academic medical center. Fletcher Allen and Central Vermont Medical Center are members of Fletcher Allen Partners, established to develop a more coordinated system of care throughout the region. Fletcher Allen’s mission is to improve the health of the people in the communities it serves by integrating patient care, education and research in a caring environment. Fletcher Allen also serves as a regional referral center -- providing advanced care to approximately one million people in Vermont and northern New York -- and as a community hospital for approximately 150,000 residents in Chittenden and Grand Isle counties. For more information about Fletcher Allen, find us online at http://www.fletcherallen.org or on our Facebook, Twitter, YouTube, and blog sites at www.fletcherallen.org/socialmedia.

About the UVM College of Medicine
Located in Burlington, the University of Vermont College of Medicine was founded in 1822 as the nation’s seventh medical school. One of only 137 medical schools in the US, the College and teaching hospital Fletcher Allen Health Care comprise Vermont’s academic medical center, where more than one-third of Vermont’s physicians were educated or trained. The College received $78 million in external research funding in 2011, and employs 762 full-time faculty and 415 staff, with over 1100 part-time faculty participating in medical education of students around the region. Enrollment currently includes 449 medical students, 147 graduate and post-doctoral students, and 290 residents and fellows.