CVRx(R), Inc., Receives IDE Approval for Rheos(TM) Baroreflex Hypertension Therapy(TM) System Pivotal Trial.MINNEAPOLIS -- CVRx([R]), Inc., a private medical device company that has developed an implantable medical device to treat high blood pressure, has received a conditional investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to begin a U.S. pivotal clinical trial that will evaluate the safety and effectiveness of the Rheos[TM] Baroreflex Hypertension Therapy[TM] System. Data from this clinical trial is intended to support the Pre-Market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for the Rheos System to the FDA. "The Rheos System represents a fundamentally new approach to therapeutic intervention for resistant hypertension," said the clinical trial's principal investigator, Dr. Thomas Pickering, professor of medicine, Columbia University Medical Center Columbia University Medical Center is the name of the medical complex associated with Columbia University, and covers several blocks (primarily between 165th and 168th Streets from the Henry Hudson Parkway to Audubon Avenue) in the Washington Heights section of Manhattan. - Presbyterian Hospital. "This pivotal study will help us further understand the potential role of this device in treating patients with difficult-to-manage high blood pressure. Reducing high blood pressure can help prevent serious heart and kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , stroke and death." Sponsored by CVRx, the blinded study is a prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , multi-center clinical trial 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 diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying . Their systolic blood pressure Systolic blood pressure Blood pressure when the heart contracts (beats). Mentioned in: Hypertension must be greater than or equal to 160 mmHg. "We have seen early positive clinical results with the Rheos System in both Europe and the United States," said Dr. Robert J. Cody, vice president for medical affairs, CVRx. "European results were recently presented at the European Society of Hypertension The European Society of Hypertension (ESH) is an international organization with objectiive to provide a stable and organized European platform for scientific exchange in hypertension. Was created in 1989 on initiative of prof. Alberto Zanchetti. and the European Society for Vascular Surgery conferences, and initial U.S. results will be presented at the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. (AHA) annual meeting in November. We are excited to continue the clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of the Rheos System in a much larger number of patients and look forward to working with our clinical investigators on this study." Early Clinical Study Results: European and U.S. feasibility clinical trials are evaluating the Rheos System in hypertension patients. European patients started enrolling in the trial in 2004. Early results for the first 12 patients were reported at the European Society of Hypertension meeting in June 2006. In this study, after three months of active Rheos therapy, systolic blood pressure was reduced by an average of 24 mmHg (189 mmHg vs. 165 mmHg). 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 High Blood Pressure: High blood pressure, also referred to as hypertension, affects about 65 million people in the United States. Hypertension is a leading cause of stroke, heart attack, heart failure and kidney disease and is estimated to cause one in every eight deaths worldwide. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications. 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 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. [c] CVRx, Inc. 2006 |
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