Natick, MA (March 15, 2012) -- Boston Scientific Corporation (NYSE: BSX) today announced Health Canada approval of the Blazer™ Open-Irrigated Catheter, the Company’s latest radiofrequency ablation (RFA) catheter designed to treat a variety of arrhythmias such as atrial fibrillation, atrial flutter, ventricular tachycardia and other supraventricular tachycardias. The product will be launched immediately in Canada.
The Blazer Open-Irrigated Catheter integrates Total Tip Cooling™ Design with the high-performance Blazer™ Catheter platform. The Total Tip Cooling Design is intended to consistently cool the entire tip electrode during radiofrequency energy delivery, resulting in reduced coagulum at the proximal edges of the tip. This is achieved through both internal cooling and external washing of the tip electrode.
“The excellent cooling profile, coupled with the high performance Blazer platform, makes this catheter an important additional option for performing simple and complex ablations,” said Felix Ayala-Parades, M.D., Chief Electrophysiologist at Sherbrooke University Hospital Centre in Quebec, who performed the first procedure in Canada using the Blazer Open-Irrigated Catheter with Santiago Rivera, M.D. “The tip temperatures were lower than conventional open-irrigated catheters during RF delivery. The catheter handling also allowed for a smooth drag lesion to be created without any gaps in the lesion set and with good contact to ensure adequate lesion creation.”
Atrial fibrillation is a rapid irregular rhythm affecting the upper chambers of the heart. Patients are most often treated with anti-arrhythmic drugs, which can be associated with adverse side effects. Cardiac ablation with an RFA catheter is being used increasingly for patients who cannot tolerate these medications.
“The Health Canada approval and launch of the Blazer Open-Irrigated Catheter in Canada are important milestones in our continued focus on advancing cardiac ablation technology,” said Hank Kucheman, Chief Executive Officer of Boston Scientific. “We are committed to expanding our Canadian electrophysiology business and improving outcomes for patients undergoing cardiac ablation procedures.”
In the U.S., the Blazer Open-Irrigated Catheter is an investigational device, limited by applicable law to investigational use only and not available for sale. The product is approved for use in CE Mark countries.
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 our electrophysiology business plans; new product launches and launch cadence; product performance; clinical outcomes 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.
Boston Scientific Corporation
Boston Scientific Corporation