RHYTHM TECHNOLOGIES FILES PMA FOR CATHETER.

Rhythm Technologies, Inc., Jacksonville, Fla., has filed its PMA with the United States FDA for The Rhythm Catheter. The Rhythm Catheter is a proprietary disposable transvenous catheter designed to deliver low energy defibrillation for the treatment of atrial and ventricular arrhythmias.

Over 120 patients at 10 US hospitals were treated with The Rhythm Catheter for chronic atrial fibrillation, ventricular tachycardia and ventricular fibrillation or cardiac arrest. The cumulative success rate for all arrhythmias was approximately 70% using monophasic shocks. Published data on The Rhythm Catheter from the European Community show a greater than 95% success rate with available biphasic defibrillators for the same patient demographics. Peter Accorti, president of Rhythm Technologies Inc. said, "We are very pleased with the results of the clinical trial. These patients represented some of the most challenging cases encountered during Electrophysiological Studies (EPS).

The investigators were able to successfully restore normal rhythm in a majority of patients with chronic (greater than 1 yr) atrial fibrillation (AF) which have been resistant to high-energy external shocks and to drug therapy. Additionally, the patients with ventricular arrhythmias presented with heart rates over 240 bpm and ejection fractions under 35%. Furthermore, all patients were treated with available external defibrillators, which delivered monophasic shocks. Given this fact, the data are even more compelling. We sincerely appreciate all the efforts and hard work from our dedicated US investigators and their staff."

Internal cardioversion and defibrillation is a much more efficient and less traumatic procedure delivering low-energy shocks directly to the inside of the heart to terminate arrhythmias i.e., potentially life-threatening abnormalities of the heart. Internal cardioversion has proved to be a significant advance in the Cardiac Rhythm Management (CRM) market. This market represents over 5 million persons world-wide with atrial and ventricular arrhythmias and will see significant growth primarily due to the increasing aging population.

Accorti further stated, "Transvenous defibrillation transformed the Implantable Defibrillator (ICD) market in the late 1980's into a billion dollar market today. It makes sense that having a disposable version of this type of product will have great clinical utility. The treatment options for patients with chronic atrial fibrillation are most exciting. We feel that The Rhythm Catheter product family may be used in virtually every EP procedure and ablation procedure where arrhythmias are encountered. Additionally, a majority of patients with chronic refractory Atrial Fibrillation may benefit significantly from these products and therapy options. Emerging markets such as Heart Failure and post CABG Atrial Fibrillation which account for significant health care expenditures may also benefit from internal cardioversion therapy."

Rhythm Technologies, Inc. is ISO9001/EN 46001 certified and the Rhythm Catheter and Accessories have the "CE Mark" and are sold in the European Community. The full family of Rhythm catheters were approved for sale into Japanese market late last year with sales and marketing efforts under way to launch these products and expand on clinical indication in Japan.

Rhythm Technologies, Inc. (Jacksonville, Fla.) a privately held medical device company, develops minimally invasive, cost-effective therapies for the treatment of cardiac arrhythmias in the Cardiac Rhythm Management market

For more information, call 904/230-1230 or visit http://www.rhythmtechnologies.com