Approvals include CONFIENT(TM) ICD, LIVIAN(TM) CRT-D and upgraded
LATITUDE(R) Patient Management System
NATICK, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Boston Scientific
Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration
(FDA) approval for three products in its Cardiac Rhythm Management
business. They are:
-- The CONFIENT(TM) implantable cardioverter defibrillator (ICD), which
helps protect patients at risk of sudden cardiac death
-- The LIVIAN(TM) cardiac resynchronization therapy defibrillator
(CRT-D), which provides cardiac resynchronization and defibrillation
therapies in one device
-- An upgraded LATITUDE(R) Patient Management System, with enhanced
remote monitoring capabilities
"Our Cardiac Rhythm Management (CRM) team is refocused on delivering therapy systems that meet physicians' needs for safety, reliability and better patient outcomes," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "These and other recent approvals are tangible examples of the team's revitalized commitment to quality and innovation."
The CONFIENT ICD features an enhanced AV (atrial ventricular) Search Hysteresis feature designed to reduce unnecessary right ventricular pacing. The device is equipped with wireless capability designed to save physicians time during implant by allowing device programming during wound closure and eliminating the need for the programming wand in the sterile field. Wireless capability also saves time at follow-up visits by offering device interrogations that can be three times faster than the Company's wanded telemetry.
The LIVIAN CRT-D enables physicians to provide patients with
individualized therapy using the following features:
-- SmartDelay(TM): quickly proposes programmable device settings, which
enables physicians to tailor individualized pacing therapies for their
-- Bi-V Trigger with ventricular rate regulation: helps physicians manage
heart failure patients with frequent atrial arrhythmias
Upgraded LATITUDE Patient Management System The upgraded LATITUDE
Patient Management system has enhanced remote monitoring capabilities that
-- A new alert in the CONFIENT ICD that notifies physicians if a
patient's percentage of right ventricular pacing increases above a
-- A new alert in the LIVIAN CRT-D that notifies physicians if a
patient's percentage of biventricular pacing falls below a
-- A programmable atrial arrhythmia burden alert in the CONFIENT ICD and
the LIVIAN CRT-D that enables physicians to detect and manage
arrhythmias. Patients with atrial fibrillation, particularly those
with heart failure, are at risk of stroke. By identifying arrhythmias
earlier, physicians can intervene with treatments to decrease this
Both the CONFIENT ICD and LIVIAN CRT-D enable physicians to manage their patients wirelessly on the LATITUDE Patient Management System. The LATITUDE system helps physicians impact patient outcomes by notifying them of changes in a patient's clinical status between normally scheduled follow-ups, enabling them to intervene earlier in a patient's care.
"These technologies are welcome improvements that are designed to provide earlier insight into changing patient conditions and enable me to devote time to patients who need me the most," said Brian Olshansky, M.D., Professor of Medicine, University of Iowa Hospitals.
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.
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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
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-- Risk Factors in Quarterly Reports on Form 10-Q we have filed or will
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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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