Boston Scientific Announces First Patient Enrollment For The Septal CRT Study

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 07 Nov 2008 - 2:00 PST

email to a friend   printer friendly   view / write opinions   rate article

Boston Scientific Corporation (NYSE: BSX) today announced that the first patient was enrolled in the SEPTAL CRT clinical study, sponsored by the Company's Cardiac Rhythm Management (CRM) group. The patient was enrolled in France by Prof. Christophe Leclercq MD from CHU-Hôpital Pontchaillou, Rennes.

SEPTAL CRT is a prospective, randomised trial designed to investigate the long-term clinical efficacy and patient outcomes of placing a right ventricular defibrillator lead in different areas of the heart for patients implanted with a Boston Scientific cardiac resynchronisation defibrillator (CRT-D). Patients will be implanted with a RELIANCE® G or SG defibrillator lead, which will be randomised for placement in either the apex of the right ventricle or in the mid-septum. Patient outcomes will be measured using several variables including evaluation of heart function by echocardiography.

"The placement of the right ventricular lead for CRT patients remains controversial," said Prof. Christophe Leclercq MD, CHU-Hôpital Pontchaillou, Rennes, France, and Principal Investigator of the study. "We can hypothesise that the mid-septal location, closer to the conduction system, could improve the efficacy of CRT therapy and thus might have a significant impact on clinical outcome. The SEPTAL CRT trial is designed to answer this crucial question with the comparison of apical and mid-septal RV lead locations."

"The SEPTAL CRT study is another example of how Boston Scientific is dedicated to providing evidence-based guidance to aid physicians in selecting optimal treatments for their patients," said Ulrich Michel, Vice President Safety and International Clinical Operations for Boston Scientific CRM.

The patient selection criteria for SEPTAL CRT allows inclusion of patients with chronic heart failure who are on optimal and stable medication and are undergoing their first implant with a Boston Scientific CRT-D device and a RELIANCE G or SG lead. The study will include up to 416 patients in centres in France and Spain.

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: http://www.bostonscientific-international.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of 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 clinical trials, scientific activities, product performance, regulatory approval of our products, competitive offerings, growth strategy and our market position. 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 IA - 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 thereafter. 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