The European Union has granted CE mark approval for the extended longevity provided by Boston Scientific’s Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
The approval was based on the data submitted to the European authorities, which shows that longevity varies for each device depending on the model type and settings.
Projected device longevity exceeds a warranty of 10 years for some ICDs, approaches eight years for CRT-D devices and is up to double that of comparable competitive device models, according to the company.
Royal Brompton and Harefield NHS Foundation Trust consultant cardiologist and arrhythmias chair Dr Vias Markides said device longevity is a key consideration for patients and their physicians.
"As patients live longer, increased device longevity can translate to fewer replacement procedures and a lower risk of complications," Markides said.
"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 EMEA senior vice president and president Michael Onuscheck said the company believes that the new labelling for its defibrillator products will provide doctors and patients with additional assurance about the longevity of the devices.
"Boston Scientific ICDs and CRT-Ds benefit from our proprietary advanced battery technology," Onuscheck said.
"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."
Image: Boston Scientific’s corporate headquarters in Natick, Massachusetts, US. Photo: Courtesy of BostonScientific.
