Boston Scientific defibrillators receive CE Mark for extended
21 November 2012
Boston Scientific Corporation (NYSE: BSX) has received CE Mark
approval for increased longevity projections for its INCEPTA, ENERGEN,
PUNCTUA, COGNIS and TELIGEN implantable cardioverter defibrillators
(ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
"We are pleased with the new labeling for our defibrillator
products which provides doctors and patients with additional
assurance about the longevity of these devices," said Michael
Onuscheck, senior vice president and president of Europe, Middle
East and Africa at Boston Scientific.
"Boston Scientific ICDs and CRT-Ds benefit from our proprietary
advanced battery technology. The new battery was first introduced in
the COGNIS and TELIGEN devices in 2008 and has now been incorporated
into our newest devices. This European approval confirms the
confidence already expressed earlier this year by the United States
Food and Drug Administration."
"Device longevity is of primary importance for patients with
devices. As patients live longer, increased device longevity can
translate to fewer replacement procedures and a lower risk of
complications," said Vias Markides, consultant cardiologist and
chair of Arrhythmias, Royal Brompton and Harefield NHS Foundation
"Reducing re-intervention also has an important impact on the
health care economy, offering substantial savings to service
commissioners and offering operational advantages for device
implanting services. Boston Scientific ICDs and CRT-D devices have
shown a substantial increase in longevity projections, which is
backed up by an impressive warranty."
For details of the warranties contact Boston Scientific.