NATICK, Mass., July 8 /PRNewswire-FirstCall/ — Boston Scientific Corporation (NYSE: BSX) today announced enrollment of the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company’s COGNIS™ cardiac resynchronization therapy defibrillators (CRT-Ds). Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure. The first patient was enrolled by Paul Coffeen, M.D., Austin Heart, Austin, Texas, where Jeffrey Whitehill, M.D., Medical Chair, Electrophysiology Department, is the site’s Principal Investigator.
When combined with the Company’s LATITUDE® Patient Management System, CRT-D sensors would be able to monitor a patient outside of a clinical setting and permit the LATITUDE system to deliver early notification to the physician when the patient’s heart failure worsens.
“Heart failure is a complex disease and physicians use a number of diagnostics to assess a patient’s condition and disease progression,” said John Boehmer, M.D., Medical Director, Heart Failure Program and Professor of Medicine, Penn State Hershey Medical Center and Principal Investigator of the MultiSENSE trial. “A multi-sensor design in an implantable device, with the predictive power of multiple data points, would enable physicians to take clinical action sooner to avoid hospitalization due to heart failure.”
“The MultiSENSE trial marks a significant step toward addressing the unmet needs of heart failure patients,” said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “Boston Scientific’s unique multi-sensor approach is designed to allow our CRT-Ds to assess the same symptoms and data a doctor evaluates when seeing a heart failure patient in the office.”
Heart failure is a debilitating condition that affects a patient’s quality of life and life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. Approximately 22 million people worldwide suffer from heart failure and nearly one million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder.
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 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 product performance, clinical outcomes, regulatory approval of our products, and our growth strategy. 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.