REDWOOD CITY, Calif., Sept. 21 /PRNewswire/ -- Radiant Medical, Inc. announced today the enrollment of the first patient in COOL MI II, an international clinical study designed to demonstrate that lowering a patient's body temperature during a heart attack will reduce the subsequent damage to the heart.
Late Sunday morning a patient was rushed to William Beaumont Hospital, Royal Oak, MI, after suffering an acute myocardial infarction (heart attack). In addition to the standard treatment for restoring normal blood flow to his heart, researchers rapidly cooled the patient to 89.6 degrees F (32 degrees C) using a novel catheter-based device known as the Reprieve(R) Endovascular Temperature Therapy System.
"By rapidly cooling the heart we hope to preserve the heart muscle, and thereby improve long-term heart function and patient survival," said Dr. Maher Rabah, who together with Dr. Simon Dixon performed the first case. "We were very pleased with the ease and speed of the procedure, and with how well the patient tolerated the reduction in temperature."
Building on the groundbreaking COOL MI study, the COOL MI II study has been designed to show that earlier, faster and deeper cooling results in a clinically significant reduction in heart damage.
"This is an important and timely clinical study," said William O'Neill, MD, Principal Investigator for the COOL MI II Trial and Corporate Chief of Cardiology at William Beaumont Hospitals. "While current reperfusion treatments are effective, there remains considerable room for improvement and additional tissue protection therapies are required". O'Neill continued, "I am thrilled to be once again collaborating in this study with such an accomplished team of clinical investigators from the world's leading research institutions."
"The clinical data clearly shows that time is critical in the treatment of patients having a heart attack," said Ken Hayes, President and CEO of Radiant Medical. "Our new Reprieve System cools over three times faster than the original technology, reaching target temperature in less than 20 minutes. This remarkable engineering accomplishment enables more effective use of the available treatment time."
"We are proud to sponsor this landmark trial," continued Hayes. "The launch of the COOL MI II trial confirms our staunch commitment to the establishment of therapeutic cooling as an effective treatment for heart attack, as well as other debilitating ischemic disorders such as stroke and cardiac arrest."
About Heart Attack
During a heart attack, blood flow is reduced or stopped in one or more of the coronary arteries that deliver blood to the heart. When this happens, the heart muscle becomes starved for blood and oxygen. This process often causes irreversible heart damage, impairing heart function and leading to an increased risk of cardiac arrest, heart failure or death. This year, an estimated 1.1 million Americans will experience a heart attack. Of these, approximately 25% of men and 38% of women will die within one year.
About the COOL MI II Clinical Trial
COOL MI II (COOLing as an Adjunctive Therapy to Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction II) is a prospective, randomized, multicenter clinical trial designed to evaluate the safety and effectiveness of endovascular cooling in the setting of acute myocardial infarction (heart attack). The study will enroll patients at 30 international sites over the next two years. The study is being conducted under an approved Investigational Device Exemption.
About the Reprieve(R) System
The Reprieve(R) System enables the rapid induction of mild to moderate hypothermia in a conscious patient. It provides very rapid, controlled cooling and rewarming. A catheter is threaded into the femoral vein in the groin and up towards the heart. Cool sterile saline (salt water) is circulated within the catheter, the catheter cools the blood as it flows past, and the blood then cools the body from the inside out. To rewarm the patient the sterile saline is simply warmed. The technology is intuitive and simple to use. Further device information can be found at www.radiantmedical.com
About Radiant Medical, Inc.
Radiant Medical, Inc., headquartered in Redwood City, California, is a private medical technology company, developing and investigating state-of-the-art endovascular temperature therapy systems to advance the treatment of patients with acute ischemic or inflammatory conditions, such as heart attack, stroke and cardiac arrest. Radiant Medical is the world leader in this emerging field and has sponsored groundbreaking trials in both acute myocardial infarction and ischemic stroke.
Radiant Medical, Inc.