Boston Scientific Announces First Use of Blazer® Open-Irrigated Catheter in U.S.
NATICK, Mass., Jan. 27, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the first use of the Blazer® Open-Irrigated Catheter in the U.S. as part of the BLOCk-CTI clinical trial. BLOCk-CTI is a prospective, randomized trial evaluating the safety and effectiveness of the Blazer Open-Irrigated Catheter in patients with sustained or recurrent Type 1 atrial flutter. The trial plans to enroll up to 240 patients at 22 sites in the U.S.
Atrial flutter is an arrhythmia associated with the right atrium of the heart that affects nearly 1 million people in the U.S. Patients with Type 1 atrial flutter may exhibit symptoms including palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation has become a first-line treatment approach for patients with recurrent Type 1 atrial flutter, demonstrating more successful short- and long-term outcomes compared to anti-arrhythmic drugs.
"The Blazer Open-Irrigated Catheter combines a new technique for irrigated ablation with the reliability of the proven Blazer platform," said Emile Daoud, M.D., Section Chief, Cardiac Electrophysiology, Ross Heart Hospital at the Ohio State University Medical Center in Columbus, who performed the first U.S. procedure. "The open-irrigated catheter performed well with excellent maneuverability, torque and catheter stability."
The Blazer Open-Irrigated Catheter integrates Total Tip Cooling Technology with the high-performance Blazer® Catheter Platform. Total Tip Cooling Technology is intended to offer consistent cooling of the entire ablation tip electrode throughout radiofrequency energy delivery.
"The first U.S. use of the Blazer Open-Irrigated Catheter highlights our continued focus on providing the most advanced ablation technologies to electrophysiologists," said Hank Kucheman, Executive Vice President and President of Boston Scientific's Cardiology, Rhythm, and Vascular Group.
In the U.S., the Blazer Open-Irrigated Catheter is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
About Boston Scientific
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.