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Clinical Trial Findings Show Significant Reduction in Blood Pressure With CVRx(R) Rheos(TM) Baroreflex Hypertension Therapy(TM) System

Posted on: Tuesday, 14 November 2006, 12:01 CST

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.1 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.2, 3

"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.

About the Rheos System: CVRx's flagship product, the Rheos Baroreflex Hypertension Therapy System, is intended for use in patients who cannot control their blood pressure with medications and lifestyle modifications. The Rheos System provides what physicians describe as a "physiological rational" method to reduce blood pressure. This implantable device is designed to reduce blood pressure by using mild electrical signals to influence the body's blood pressure regulation system, called the baroreflex.

About the Rheos Pivotal Trial: Sponsored by CVRx, the Rheos Pivotal Trial is a blinded, prospective, randomized, multi-center clinical study that will be conducted at up to 40 medical sites in the United States. The study seeks to determine the safety and effectiveness of the Rheos System when used in drug-resistant hypertension patients. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic. Their systolic blood pressure must be greater than or equal to 160 mmHg.

About CVRx: CVRx, Inc., was founded in 2001 and is headquartered in Minneapolis. It is a private company and its senior management and technical teams have many years of experience commercializing implantable medical devices. For more information visit www.cvrx.com.

Footnotes:

1 Heart Disease and Stroke Statistics. American Heart Association -- 2006 Update.

2 U.S. Renal Data System. USRDS 2003 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2003.

3 Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.

CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc.

© CVRx, Inc. 2006

Source: Business Wire

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