NATICK, Mass., May 19 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of two large-scale clinical studies to evaluate the benefits of the LATITUDE® Patient Management system in managing heart failure patients. The system includes the Cardiac Rhythm Management industry's first and only wireless weight scale, wireless blood pressure cuff and monitoring of patient symptoms. It is also the industry's only system that provides automatic alerting to physicians of heart failure conditions using a wireless weight scale. An abrupt change in weight could indicate worsening heart failure. Close management of weight and other parameters is recommended by the recently issued American College of Cardiology and American Heart Association Class I guidelines for managing heart failure patients.
DECODE is a study designed to evaluate the novel diagnostic information from the LATITUDE and RENEWAL 3 RF system for the prediction and ultimate prevention of hospitalizations for heart failure. Heart failure has an annual direct cost of more than $26 billion in the U.S. and is the number one reason for hospitalizations. The national principal investigators for DECODE are F. Roosevelt Gilliam III, M.D., Professor of Clinical Medicine, Duke University, Durham, North Carolina and Greg Ewald, M.D., Director of the Heart Failure and Cardiac Transplant program, Washington University School of Medicine, St. Louis, Missouri. The first enrollments in this study have now occurred. "In the recent ACC/AHA guidelines for heart failure, close monitoring of a patient's weight and activities of daily living are a Class I recommendation. There is ample evidence that this type of approach can result in fewer hospitalizations for heart failure patients," said Dr. Ewald. "With the LATITUDE system we can monitor these and other cardiac parameters wirelessly and from the patient's home. The potential for patient benefit is significant."
RAPID-RF is a multi-center, prospective registry investigating physician and patient responses to notifications automatically transmitted from the patient's home via LATITUDE Active Monitoring. The purpose of the study is to evaluate medical interventions associated with device status and heart failure-related symptom alerts. The national principal investigators for RAPID-RF are Leslie Saxon, M.D., Director of Cardiac Electrophysiology, University of Southern California, Los Angeles, California and John Boehmer, M.D., Medical Director of the Heart Failure Program at the Penn State College of Medicine, Hershey, Pennsylvania. Dr. Bruce Goldner, M.D., performed the first implant on May 18, at Long Island Jewish Hospital in New Hyde Park, New York.
"LATITUDE Active Monitoring works without the need of an office visit by providing integrated information on a patient's heart failure and arrhythmia status so all physician stakeholders can work together to better manage their device patients. It also delivers confidence and assurance to physicians by providing two types of notifications depending on the severity of the alert," said Dr. Saxon. "The purpose of RAPID RF is to evaluate the nature of these alerts so that physicians may be better able to understand how to intervene earlier to improve patient outcomes."
The LATITUDE Patient Management system consists of four components: * CONTAK RENEWAL 3RF Cardiac Resynchronization Therapy Defibrillator (CRT-D): The company's first wireless enabled implantable device. * LATITUDE Communicator: An in-home monitoring unit that automatically and wirelessly reads implantable device information at times specified by the patient's physician. * LATITUDE Website: The secure website that provides anytime, anywhere access to -- and a digital archive of -- device and patient data collected by the LATITUDE Communicator. * ZOOM LATITUDE Programmer: A wireless, LATITUDE-compatible programmer designed to save physicians time at implant and follow-up.
To date, there have been more than 1,500 patients enrolled in the LATITUDE Patient Management system.
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.com/.
This press release contains forward-looking statements. Boston Scientific 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 Media Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or Paul
Donovan, Media Relations, +1-508-650-8541, both of Boston Scientific
Web site: http://www.bostonscientific.com/