NATICK, Mass., Oct. 2 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced a U.S. Food and Drug Administration (FDA) approval that permits the LATITUDE® Patient Management System to now be used in virtually all of the Company's implantable defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This approval increases the number of patients eligible to receive the benefits of home monitoring by more than 150,000 in the United States.
LATITUDE is the industry's first and most broadly adopted wireless remote patient management system. The approval announced today makes LATITUDE home monitoring available to eligible patients with non-wireless devices, supporting nearly all models in the PRIZM and VITALITY families of ICDs and the RENEWAL family of CRT-Ds. To receive the benefits of remote monitoring, eligible patients can be enrolled in the LATITUDE system by their physician. Boston Scientific anticipates this technology will be available beginning next year.
Patients with non-wireless devices will now be able to benefit from the convenience of remote follow-ups and the knowledge that both their heart failure and device status can be monitored while they are at home. Regular monitoring of a patient's heart failure status allows for earlier notification of clinical events, giving physicians the opportunity to intervene faster and potentially prevent further complications.
"LATITUDE provides significant benefit to patients and their clinicians," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We are pleased to be making LATITUDE available to virtually all our ICD and CRT-D patients with new and previously implanted devices. Because we believe this is an important benefit for patients, we are making this technology available with no ongoing charges."
LATITUDE is the only remote patient management system aligned with both the American College of Cardiology/American Heart Association 2005 Heart Failure Guidelines for monitoring weight, blood pressure and quality-of-life symptoms and the Heart Rhythm Society guidelines for automatic device surveillance.
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. The Company 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 litigation, clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 (office) 617-834-8595 (mobile) Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Annette Ruzicka 651-582-6161 (office) 763-458-4193 (mobile) Media Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569 (office) or
+1-617-834-8595 (mobile), Paul Donovan, +1-508-650-8541 (office) or
+1-508-667-5165 (mobile), or Annette Ruzicka, +1-651-582-6161 (office) or
+1-763-458-4193 (mobile), both in Media Relations, all of Boston Scientific
Web site: http://www.bostonscientific.com/