|
|
|
November 14, 2006
Clinical Trial Findings Show Significant Reduction in Blood Pressure with CVRx Rheos™ Baroreflex Hypertension Therapy™ System
CVRx harnesses a well-understood biological reflex for the treatment of two of the most significant unmet needs in clinical medicine today: hypertension and congestive heart failure. The company has pioneered a device/electrode combination to stimulate the carotid sinus, triggering a reduction in blood pressure, even in patients who display high resistance to existing blood pressure medicines. Below, CVRx reports on data from the first 10 US patients from its US study, demonstrating average systolic and diastolic blood pressure drops of 22 and 18 mmHg respectively.
--------------------------------
Early findings from the Rheos™ Trial show a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater. The ongoing study is assessing the safety and clinical efficacy of the Rheos™ Baroreflex Hypertension Therapy™ System, an implantable device for the treatment of hypertension in patients who cannot control their blood pressure with medications and lifestyle modifications. CVRx, a private medical device company in Minneapolis, developed the Rheos System. Dr. John Bisognano of the University of Rochester, Rochester, N.Y., and a lead investigator of the Rheos Trial, presented the study findings today at the American Heart Association 2006 Scientific Sessions in Chicago.
High blood pressure, also referred to as hypertension,
affects about 65 million people in the United States.
Hypertension is estimated to cause one in every eight
deaths worldwide. Each increase of 20 mmHg in systolic
blood pressure or 10 mmHg in diastolic blood pressure
above normal levels is associated with a two-fold increase
in death rates from stroke, coronary heart disease and
other vascular causes. Approximately 25 percent of people
with hypertension cannot control their high blood pressure,
despite the use of multiple medications.
"The Rheos System is a novel device that activates the carotid baroreflex, the body's own system for regulating blood pressure," said Dr. Bisognano. "We are pleased with the clinical results to date and look forward to expanding the clinical evaluation of the Rheos System. New approaches to the widespread, chronic and costly problem of hypertension are needed. The Rheos System has the potential to prevent the progression to more serious illnesses, including heart and kidney disease, stroke and death."
The Rheos Trial is designed to assess device safety and efficacy in patients with systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including one diuretic. The presentation reported on the first 10 U.S. patients enrolled in the trial. After one month of surgical recovery, baseline blood pressure was assessed and the device was activated. Three months of active Rheos therapy reduced systolic blood pressure by an average of 22 mmHg (180 mmHg vs. 158 mmHg) and diastolic blood pressure by an average of 18 mmHg (105 mmHg vs. 87 mmHg), using office cuff measurements. The implants were well tolerated and there were no unanticipated serious adverse events related to the system or procedure.
In October, CVRx received a conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a U.S. pivotal clinical trial that will evaluate the safety and effectiveness of the Rheos™ Baroreflex Hypertension Therapy™ System in a much larger number of patients.
"These interim clinical results are favorable and promising for the many people with drug-resistant hypertension," said Nadim Yared, president and CEO of CVRx. "We are excited about launching our pivotal trial and look forward to working with our investigators."
In Europe, patients began enrolling in a feasibility trial
in 2004. Early results for the first 12 patients were
reported at the European Society of Hypertension meeting
in June 2006. In that study, after three months of active
Rheos therapy, systolic blood pressure was reduced by
an average of 24 mmHg (189 mmHg vs. 165 mmHg), using office
cuff measurements. There were no unanticipated serious
adverse events related to the system or procedures. Further
information on these study results can be found on the
CVRx Web site at www.cvrx.com.
Back to News
|
|
| |
