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 Reprieve(R) 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 Reprieve(R) System
The Reprieve(R) 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.
Radiant Medical, Inc
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