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PRORYTHM REPORTS USE OF STEERABLE HIFU ABALATION SYSTEM.

ProRhythm, Inc., Setauket, N.Y (formerly known as Transurgical, Inc.) has announced the first clinical use of the Steerable HIFU (High Intensity Focused Ultrasound) Ablation System in Hamburg, Germany. The world-renowned electrophysiology team at St. Georg's Hospital, under the direction of Prof. Karl-Heinz Kuck, successfully treated 8 patients with the latest generation of this novel system to treat Atrial Fibrillation. While these procedures continue to evaluate the clinical efficacy of the HIFU Ablation System, they incorporated a significant improvement in catheter design, active steerability.

The Atrial Fibrillation (AF) ablation procedure, commonly called Pulmonary Vein Isolation, utilizes ProRhythm's proprietary balloon catheter that 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. Proper positioning of the HIFU Catheter at the pulmonary vein's entrance into the heart and successful energy delivery are important in the process of achieving successful Pulmonary Vein Isolation.

The new Steerable HIFU Catheter is designed to allow physicians to more easily position the catheter accurately at the site of ablation. In this initial series, investigators were able to position the catheter with relative ease at 100% of the pulmonary veins. This ability could dramatically reduce the overall procedure time and, by allowing the user to access all four pulmonary veins, could result in improved procedural success rates.

"We are very pleased with the results of these initial procedures with the Steerable HIFU Ablation Catheter," said Prof. Karl-Heinz Kuck. "Our past clinical experience with the HIFU System has demonstrated the ability of HIFU to isolate pulmonary veins and reduce or eliminate Atrial Fibrillation. I believe that these latest improvements may result in procedures of 1 to 2 hours for most patients."

"The new product design combines steerability with the advantages of HIFU ablation, most importantly HIFU's non-thrombogenic nature," said Reinhard Warnking, president and CEO of ProRhythm. "This simple design, eliminates the need for steerable sheaths and complicated accessories and may enhance the user's ability to quickly and easily reach all pulmonary veins."

ProRhythm anticipates that its HIFU Ablation System will be approved for commercialization in Europe in the first half of 2005.

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, approximately 8 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.

Atrial Fibrillation is an abnormal rhythm of the heart which may increase the risk of stroke and other complications due to the irregular pumping action of the atrium.

ProRhythm's HIFU system is currently under investigation in clinical trials in Europe and 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.

For more information, visit http://www.prorhythm.com or call 631/689-2002 ext. 34.
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Publication:Biotech Equipment Update
Date:Feb 1, 2005
Words:558
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