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October 16, 2006
CVRx Receives IDE Approval for Rheos™ Baroreflex Hypertension Therapy™ System Pivotal Trial
CVRx harnesses a well-understood biological reflex for the treatment of two of the most significant unmet needs in clinical medicine today: hypertension and congestive heart failure. The company has pioneered a device/electrode combination to stimulate the carotid sinus, triggering a reduction in blood pressure, even in patients who display high resistance to existing blood pressure medicines. Initial clinical data, presented earlier this year in Europe, is very promising. Below, CVRx announces the approval from the FDA to begin pivotal trial testing. Click here to read the Medical Device Daily article reporting this news.
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CVRx harnesses a well-understood biological reflex for the treatment of two of the most significant unmet needs in clinical medicine today: hypertension and congestive heart failure. The company has pioneered a device/electrode combination to stimulate the carotid sinus, triggering a reduction in blood pressure, even in patients who display high resistance to existing blood pressure medicines. Initial clinical data, presented earlier this year in Europe, is very promising. Below, CVRx announces the approval from the FDA to begin pivotal trial testing.
CVRx has 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. Data from this clinical trial is intended to support the Pre-Market Approval (PMA) 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 - 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, stroke and death."
Sponsored by CVRx, the blinded study is a prospective, randomized, 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. Their systolic blood pressure 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 and the European Society for Vascular Surgery conferences, and initial U.S. results will be presented at the American Heart Association (AHA) annual meeting in November. We are excited to continue the clinical evaluation 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.
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