RONKONKOMA, N.Y., Jan. 4 /PRNewswire/ -- ProRhythm, Inc., (PRI) today announced the conditional approval by the United States Food and Drug Administration (FDA) allowing the company to proceed into the pivotal phase of the Investigational Device Exemption (IDE) Trial for the treatment of symptomatic, paroxysmal Atrial Fibrillation utilizing the company’s proprietary HIFU (High Intensity Focused Ultrasound) Ablation System. This marks a significant step in the approval process for the HIFU Ablation System and comes after the successful conclusion of the acute feasibility phase.
The pivotal trial, known as “focusAF”, will involve U.S. cardiac electrophysiology centers that specialize in the treatment of Atrial Fibrillation (AF). 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. Enrollment in the trial is expected to begin in the 1st Quarter of 2006.
The feasibility trial featured PRI’s advanced, steerable HIFU Ablation Balloon Catheter. Active steerability allows the catheter to be moved throughout the left atrium of the heart and facilitates placement of the catheter at each of the four pulmonary veins -- the target treatment sites during this procedure.
Participating in the first phase of the IDE were medical teams from three leading electrophysiology centers: University of Oklahoma Medical Center, Johns Hopkins Hospital, and The Cleveland Clinic Foundation.
“We are extremely pleased with the results of the feasibility phase of the IDE trial, and continue to be very excited by the potential of HIFU for the treatment of Atrial Fibrillation,” said Dr. Warren Jackman of the University of Oklahoma Medical Center, who serves as Principal Investigator for the IDE trial. “The use of HIFU for cardiac ablation provides us with a new and potentially powerful tool to treat patients who suffer from AF, without the limitations of current technologies.”
“This marks a significant event in our company’s history,” said Reinhard Warnking, President and CEO of ProRhythm. “Our HIFU Ablation System is currently approved for use to treat AF in Europe and we now look forward to completing this next phase of the U.S. approval process and moving towards U.S. commercialization. We remain convinced that HIFU is the ideal energy for the treatment of AF.”
The HIFU Ablation Catheter utilizes High Intensity Focused Ultrasound which is shaped, focused and delivered through a unique balloon to ablate cardiac tissue in the left atrium of the heart, a procedure commonly called pulmonary vein isolation. Introduced through a vein in the patient’s leg, the HIFU Catheter is advanced into the left atrium. Controlled, discrete atrial lesions are created around the pulmonary veins by the HIFU Catheter which is controlled by ProRhythm’s proprietary automated HIFU Ablation System. These lesions are designed to stop unwanted electrical impulses from disrupting the heart’s normal rhythm.
European clinical trials have demonstrated that a significant percentage of patients undergoing the HIFU ablation procedure have experienced complete elimination of AF symptoms with a single treatment procedure.
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). 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 may 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.
CONTACT: Mr. Richard Fischer, Chief Financial Officer of ProRhythm Inc.,+1-631-981-3907, ext. 105, rfischer@prorhythm.com
Web site: http://www.prorhythm.com/
