Memorial Health Teams Up to Perform Surgical Breakthrough
December 18, 2008
Memorial Hospital and Jacksonville Center for Clinical Research (JCCR,) implanted its first medical device in a patient to treat uncontrolled high blood pressure, becoming one of the first hospitals in the United States to perform the surgical procedure. Dr. J. Theodore Wingard, cardiothoracic and vascular surgeon at Memorial Hospital, implanted the new state-of-the-art device. The patient is one of the first to be studied in the Rheos™ Pivotal Trial, an FDA-approved clinical trial of an implantable medical device to treat hypertension.
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™ Baroreflex Hypertension Therapy™ 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 Dr. Michael Koren, CEO & Medical Director of JCCR. “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 reduce blood pressure and improve cardiovascular function.”
Investigators at JCCR and Memorial 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.
About 65 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.1 It is a major risk factor for cardiovascular disease, morbidity and mortality, estimated to cause one in every eight deaths worldwide. Yearly costs to treat hypertension in the U.S. are estimated at $59.7 billion. It is a condition that needs new treatment solutions.
HOW TO ENROLL
For information on patient enrollment in the Rheos Trial at Jacksonville Center for Clinical Research, please contact the Jacksonville Center for Clinical Research at (904) 730-0101.
ABOUT JCCR: Since 1997, Jacksonville Center for Clinical Research has been a leader in high quality clinical research involving community based physicians. Led by Nationally recognized clinical trialist, we have grown to become the largest independent clinical research organization in Northern Florida. Currently we are conducting research throughout the state of Florida with a panel of nearly 100 physicians in multiple therapeutic areas. Our staff is organized in clinical teams. These teams provide depth and continuity during research coordination and allow for immediate responsiveness to the needs of sponsors and CROs.
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. The CVRx senior management and technical teams have many years of experience commercializing implantable medical devices. The company is well-financed and supported by an experienced board of directors. CVRx has established a world-class scientific advisory board, which includes thought leading professors and physicians, both in the U.S. and Europe, who are well known in the field of hypertension and other disciplines. Caution: The CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only. CVRx, Rheos and Baroreflex Hypertension Therapy are trademarks of CVRx Inc. All other trademarks are property of their respective owners.
ABOUT MEMORIAL HEALTH: Fully accredited by the Joint Commission, Memorial Health, consisting of Memorial Hospital, Orange Park Medical Center and Specialty Hospital, is known as a leader in quality, compassionate healthcare with a reputation maintained through excellent staff, along with programs of technological advances, growth and expansion to meet the ongoing needs of the community. Memorial Health serves the entire First Coast area. For further information about services, facilities and physicians, please go to www.memorialhospitaljax.com; www.opmedical.com or www.specialtyhospitaljax.com