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Boston Scientific Announces FDA Approval of the EPT-1000 XP™ Cardiac Ablation System for the Treatment of Atrial Flutter |
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First and only 10 mm cardiac ablation catheter and 100-watt radiofrequency generator approved in the U.S.
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NATICK, Mass., Aug. 27 -- Boston Scientific Corporation (NYSE: BSX - News) announced today that it has received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its EPT- 1000 XP™ Cardiac Ablation System for the treatment of atrial flutter. It has been estimated that there are more than 200,000 new patients diagnosed with atrial flutter each year in the United States. The abnormal electrical signal causing atrial flutter occurs in the right atrium, in a circular pattern. Successful ablation procedures occur when a linear lesion is created across the tricuspid isthmus. This lesion interrupts the abnormal electrical circuit in a bi-directional manner, allowing the heart to return to normal rhythm permanently. The EPT-1000 XP Cardiac Ablation System allows for 8 mm and 10 mm tip electrodes to be used with up to 100-watts of radiofrequency energy to treat atrial flutter. "The EPT-1000 XP Cardiac Ablation system provides increased benefit in the treatment of patients with atrial flutter," said Gregory Feld, M.D., Professor of Medicine, Director of the Electrophysiology Program at the University of California San Diego Medical Center and Principal Investigator of the clinical trial. "Our experience in treating atrial flutter shows an advantage to using a 10 mm tip electrode, such as the BLAZER II XP™ catheter, and a power generator with up to 100 watts of radiofrequency energy. The results of this multi-center study show shorter procedure times with fewer ablations and a chronic success rate for atrial flutter in excess of 96 percent. At present Boston Scientific is the only company that has developed an ablation catheter with a 10 mm tip electrode and a 100 watt radiofrequency generator." "We are very excited to have received approval for the first 100-watt radiofrequency system used in the treatment of atrial flutter," said Tom Coen, President of Boston Scientific's Electrophysiology business. "Evolutionary in design, the EPT-1000 XP system has demonstrated excellent results when compared with 50-watt and 70-watt systems on the market. We anticipate that the familiar user interface of the generator and predictable performance of the catheter will facilitate rapid market adoption." Dr. Robert Mittleman, Associate Medical Director at Boston Scientific, noted that "From our clinical trial study results, patients with atrial flutter who had an ablation with the EPT-1000XP Cardiac Ablation System demonstrated a dramatic improvement in their quality of life one month after the procedure, and this improvement persisted through the six month measurement period. They also displayed a marked reduction in both arrhythmia-related symptoms and the use of medications to treat this condition." Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com. This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with litigation, clinical trials, the regulatory approval process, reimbursement policies commercialization of new technologies and other factors described in the Company's filings with the Securities and Exchange Commission.
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