Florida Hospital Leads The Country In Implant Medical Device

Florida Hospital is One of the First Hospitals in the Country to Surgically Implant an Investigational Medical Device to Treat Hypertension

 Device Stimulates Body's Natural System of Lowering Blood Pressure

ORLANDO, Fla., Aug. 21, 2007 - Today, Florida Hospital Orlando implanted its first investigational medical device in a patient to treat uncontrolled high blood pressure, becoming the first hospital in Florida and one of the first hospitals in the United States to perform the surgical procedure.  The patient is one of the first to be studied in the Rheos^TM Pivotal Trial, an FDA-approved clinical trial of an implantable medical device to treat hypertension, which affects approximately 72 million people in the United States.

Sponsored by CVRx Inc., the Minneapolis company that developed the proprietary technology to be studied, the trial aims to demonstrate that the product, the CVRx Rheos^TM Baroreflex Hypertension Therapy^TM System, is a safe and effective treatment for patients with high blood pressure that is not controlled with medications and lifestyle modifications.

"Rheos Therapy is an innovative treatment that is designed to electrically activate the baroreflex, the body's own monitoring system to watch and control blood pressure," explained H.B. Karunaratne, MD, cardiologist and lead trial investigator at Florida Hospital.  "We have been waiting to try this 'physiological rational' treatment ever since medical and scientific data emerged to support taking advantage of the function of the body's natural pressure sensors to control blood pressure."

Investigators at Florida Hospital are screening patients to establish their eligibility for participation in the Rheos Pivotal Trial.  To qualify, patients must have persistent high blood pressure despite aggressive treatment with medications.  Qualifying patients will also be screened to ensure they are good candidates for the surgical implant procedure and for baroreflex therapy.  The CVRx Rheos System is an investigational device and is limited by federal law to investigational use only.

ABOUT HYPERTENSION

According to the American Heart Association, approximately 72 million people in the United States suffer from hypertension, which can affect individuals of any age, gender or race.  Twenty-five percent of the people with hypertension have uncontrolled high blood pressure, despite the use of medications.  It is a major risk factor for cardiovascular disease, morbidity and mortality, and is estimated to cause one in every eight deaths worldwide.  Yearly costs to treat hypertension in the U.S. are estimated at $59.7 billion. 

ABOUT FLORIDA HOSPITAL

With seven hospitals and 16 Central Care walk-in medical centers, Florida Hospital is one of the largest not-for-profit hospitals in the country, caring for more than one million patients each year.  The more than 1,900-bed hospital system has several major centers of excellence including Cardiology, Cancer, Neuroscience, Orthopaedics, and Diabetes.

ABOUT CVRx

CVRx is a private company located in Minneapolis.  The company has developed proprietary technology for the treatment of hypertension that cannot be controlled with medications, and is the first company to develop an implantable medical device to treat this condition. 

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