ProRhythm Initiates U.S. Pivotal Trial For HIFU Ablation System
The "focusAF" trial, the pivotal trial in the FDA approval process, will involve over 20 U.S. cardiac electrophysiology centers that specialize in the treatment of Atrial Fibrillation. AF is an abnormal rhythm of the heart, which can lead to stroke and other complications due to the irregular pumping action of the atrium. It is estimated that AF currently afflicts in excess of 6 million people worldwide.
The AF ablation procedure, commonly called Pulmonary Vein Isolation, utilizes ProRhythm's proprietary balloon catheter which is inserted through a vein in the leg of the patient and advanced into the left atrium of the heart. Controlled, discrete ablation lesions around the pulmonary veins, created with the HIFU Catheter, are intended to prevent unwanted electrical impulses from disrupting the heart's normal rhythm.
The milestone procedure was performed at Beaumont Hospital in Royal Oak, Michigan by Dr. David Haines. During the procedure, Dr. Haines was able to position the HIFU Ablation Catheter at each of the 4 pulmonary veins and successfully block electrical conduction from each of the pulmonary veins to the left atrium of the heart.
"The HIFU catheter performed well in this procedure. The system was able to deliver energy to the intended locations in a highly efficient and effective manner. We are hopeful that the HIFU procedure will allow the patients to lead a life that is free of Atrial Fibrillation," said Dr. Haines, Director, Heart Rhythm Center at Beaumont Hospital, following the procedure. "We are pleased to be participating in this study as it could provide us with a powerful new tool in the treatment of AF."
"The initiation of the pivotal study is a critical step along the path toward commercialization of our HIFU technology in the United States," said Reinhard Warnking, President and CEO of ProRhythm. "The acute results of this first procedure mirror the results seen in the feasibility phase of the trial. We are optimistic that long-term follow-up will demonstrate the value of HIFU in the treatment of atrial fibrillation."
About Beaumont Hospital
Beaumont is Michigan's, and one of the nation's, most experienced providers of heart care, ranking tops in Michigan and 12th overall on the 2006 U.S. News & World Report list of the "Top 50" hospitals for Heart and Heart Surgery. Beaumont offers comprehensive, state-of-the-art heart care at its Royal Oak and Troy hospitals and is dedicated to the prevention, diagnosis and treatment of heart problems. Visit Beaumont on the web at http://www.beaumonthospitals.com.
About ProRhythm
Since 1997, ProRhythm has pioneered the application of HIFU to advance the minimally invasive treatment of complex medical conditions. In recent years ProRhythm has concentrated its efforts on the development of HIFU for the treatment of a debilitating arrhythmia, atrial fibrillation. AF is an uncontrollable, rapid, heartbeat that results in a significant decline in the quality of life and may lead to serious complications. Globally, in excess of 6 million people are afflicted with AF and the current treatment options are expensive, often inadequate and non-curative, as with the case of drug therapy.
ProRhythm's HIFU Ablation System is currently under investigation in clinical trials in the United States to treat AF. ProRhythm believes that its technology will eventually play a significant role in improving the lives of countless individuals who are afflicted by atrial fibrillation.
Further information can be found at http://www.prorhythm.com.
ProRhythm, Inc.
http://www.prorhythm.com
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