PARIS, November 20, 2012 -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.
Projected device longevity exceeds 10 years for some models of Boston Scientific ICDs, approaches eight years for its CRT-D devices, and is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years*. Depending on the model, the device warranties are also up to twice as long as other currently-marketed comparable devices.
"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 Stated 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 Trust, London. "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."
* Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.
1. PUNCTUA™ ICD, ENERGEN™ ICD, INCEPTA™ ICD - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 358362-006, 5-22-12; TELIGEN® 100 - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 357449-010, 5-22-12; PUNCTUA™ CRT-D, ENERGEN™ CRT-D, INCEPTA™ CRT-D - PHYSICIAN'S
TECHNICAL MANUAL Part Number: 358373-007, 5-22-12; COGNIS® 100-D - PHYSICIAN'S TECHNICAL MANUAL Part Number: 357483-012, 5-22-12