Healthcare Industry News: hypothermia
News Release - October 24, 2006
Radiant Medical Initiates Clinical Trial of Therapeutic Cooling for Kidney ProtectionCOOL RCN Randomized Trial for Prevention of Radiocontrast Nephropathy
REDWOOD CITY, Calif., Oct. 24 (HSMN NewsFeed) -- Radiant Medical, Inc., a private medical technology company focused on the research and development of endovascular therapeutic hypothermia, today announced the initiation of the COOL RCN Trial, a safety and efficacy study of catheter-based cooling in patients undergoing cardiac catheterization who are at risk of developing radiocontrast nephropathy (RCN).
Contemporary clinical guidelines define RCN as an acute decline in kidney function after the systemic administration of contrast agents. RCN is a common cause of acute kidney failure associated with prolonged hospitalization, temporary or permanent hemodialysis, significant morbidity, mortality, and cost.
"Patients with pre-existing renal insufficiency or diabetes are at particularly high risk of developing RCN after cardiac catheterization," said Kenneth G. Hayes, President and Chief Executive Officer of Radiant Medical. "Unfortunately, heart disease and kidney disorders frequently go hand in hand, so a large number of patients requiring cardiac catheterization do have renal insufficiency or diabetes and could benefit from an adjunctive therapy to reduce the risk of RCN. In recent years, numerous RCN studies have investigated preventive therapies with mixed results. One new potential therapy is mild hypothermia to protect the kidneys of high risk patients while they are undergoing cardiac catheterization."
"The COOL RCN (COOLing to Prevent RadioContrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization) Trial is a prospective, randomized, multicenter clinical study designed to evaluate the safety and effectiveness of endovascular cooling using Radiant Medical's state-of-the-art ReprieveŽ System for preventing RCN in high risk patients," stated Craig Straley, Vice President of Clinical Affairs. "The pivotal study is being conducted at 35 sites and will enroll 400 patients. The Principal Investigator is Gregg W. Stone, M.D., Professor of Medicine and the Director of Cardiovascular Research and Education, Center for Interventional Vascular Therapy at Columbia University Medical Center, and Chairman of the Cardiovascular Research Foundation."
About the ReprieveŽ System
The ReprieveŽ Endovascular Temperature Therapy System enables the rapid induction of hypothermia in a conscious or unconscious patient by use of a venous heat exchange catheter. It provides very rapid, precise cooling, maintenance, and rewarming of the patient's core body temperature. A catheter is threaded into the femoral vein and positioned in the inferior vena cava. As cool sterile saline is circulated within the catheter, blood flowing past the catheter is cooled, and the blood then reduces the body temperature. To rewarm the patient, the sterile saline within the catheter is simply warmed.
About Radiant Medical, Inc.
Radiant Medical, Inc., headquartered in Redwood City, California, is a private medical technology company, researching and developing novel endovascular temperature therapy systems to advance the treatment of patients with acute ischemic or inflammatory medical conditions, such as heart attack, radiocontrast nephropathy, stroke and cardiac arrest. Radiant Medical is one of the leaders in this emerging field and has sponsored groundbreaking clinical research in heart, brain and kidney protection.
Source: Radiant Medical
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