Healthcare Industry News:  CVRx 

Devices Cardiology

 News Release - March 25, 2007

European and U.S. Clinical Trial Findings Show Significant Reduction in Blood Pressure with CVRx(R) Rheos(TM) Baroreflex Hypertension Therapy(TM) System

Data Presented at Late-Breaking Emerging Technologies and Innovations Session at the American College of Cardiology's 56th Scientific Sessions

Rheos Pivotal Trial Under Way



MINNEAPOLIS & NEW ORLEANS--(HSMN NewsFeed)--The millions of people who cannot control their high blood pressure (hypertension) with drug therapy may have a new option in the future - an implantable device. The Rheos(TM) Baroreflex Hypertension Therapy(TM) System, developed by Minneapolis-based CVRx, Inc., is the first implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death.



"We are pleased with the early clinical results to date and are optimistic that this novel treatment approach could offer a new option for patients with drug-resistant hypertension," said Professor Peter de Leeuw, professor of medicine/ hypertension at the University of Maastricht in The Netherlands. "The Rheos System activates the carotid baroreflex, the body's own system for regulating blood pressure. Hypertension is a widespread, growing and very costly condition. The Rheos System may prevent progression to more serious illnesses and death."

Preliminary data from European and U.S. early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented today by Principal Investigator Professor de Leeuw, as part of the Late-Breaking Emerging Technologies Session (Session No. 2406) at the 56th Annual Scientific Session of the American College of Cardiology (ACC). The findings show a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The trials are assessing the safety and clinical efficacy of the Rheos System.

The presentation at ACC reported on the following office cuff measurement results after six months of active Rheos therapy for the first 21 European and U.S. patients enrolled in these trials at 10 medical centers:

  • Systolic blood pressure was reduced by an average of 21 mmHg (187 mmHg vs.166 mmHg); and

  • Diastolic blood pressure was reduced by an average of 16 mmHg (112 mmHg vs. 96 mmHg).

The Rheos implants were well tolerated, and there were no unanticipated adverse events related to the system or procedure. Further information on these study results can be found on the CVRx Web site at www.CVRx.com.

"These favorable results are promising for the many people with drug-resistant hypertension," said Nadim Yared, president and CEO of CVRx. "We are expanding the scope of the Rheos System evaluation with a pivotal trial that is now under way. We have begun enrolling patients and look forward to advancing our understanding of the Rheos System and therapy."

Rheos Pivotal Trial in Progress

In October 2006, CVRx received conditional investigational device exemption (IDE) approval from the Food and Drug Administration to begin a U.S. pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System in a much larger number of patients. The blinded study is a prospective, randomized, multi-center clinical trial that will be conducted at up to 50 medical sites. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic, and their systolic blood pressure must be greater than or equal to 160 mmHg. Results from this study are intended to support the Pre-Market Approval (PMA) application for the Rheos System to the FDA. For information about enrolling in the Rheos Pivotal Trial, go to www.CVRx.com.

Additional Rheos Studies Presented at ACC

Findings from two pre-clinical studies that evaluated the Rheos System in canine subjects with heart failure are also being presented at ACC. In both studies, the Rheos System was found to improve the function of the left ventricle, the heart's main pumping chamber, in canines. Dr. Hani N. Sabbah, of the Henry Ford Health System in Detroit, will present one study (Abstract No. 348388) on Tuesday, March 27 (Session No. 829). Dr. Ramesh C. Gupta, also from Henry Ford Health System will discuss a second study (Abstract No. 346972) in Poster Session No. 1004 on Sunday, March 25.

The Rheos System: Working with the Body's Own Mechanisms

The Rheos System provides a "physiological rational" method to reduce blood pressure. The system's proprietary technology uses the body's own natural blood pressure regulation system (baroreflex) to control blood pressure. The Rheos System includes:

  • A small pulse generator that is implanted under the collar bone;

  • Two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and

  • The Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.

The system electronically activates the baroreflex, which sends signals to the brain suggesting a blood pressure increase. Then, the brain acts to lower blood pressure by sending signals to various parts of the body to reduce blood pressure, including the blood vessels, heart and kidneys.

Hypertension: The Need for a New Treatment Option

High blood pressure, also referred to as hypertension, affects about 65 million people in the United States alone.(1) Hypertension is estimated to cause one in every eight deaths worldwide. Each incremental 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)

Editor's Note: Blood pressure is typically recorded as two numbers -- the systolic pressure (top number) over the diastolic pressure (bottom number). The systolic pressure is the pressure of blood in the vessels when the heart contracts. Diastolic pressure is the pressure of the blood between heartbeats, when the heart is at rest and is refilling.

About CVRx, Inc.

CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. 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.


Source: CVRx

Issuer of this News Release is solely responsible for its content.
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