Boston Scientific has obtained the CE mark approval for the extended longevity provided by its INCEPTA, ENERGEN, PUNCTUA, COGNIS and TELIGEN implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
The approval was based on the data submitted to the European authorities, which show that longevity varies for each device depending on the model type and settings.
Projected device longevity exceeds a warranty of 10 years for some models of the company’s ICDs, approaches eight years for CRT-D devices and is up to double that of comparable competitive device models, claims the company.
Royal Brompton and Harefield NHS Foundation Trust cardiologist consultant and arrhythmias chair Vias Markides said device longevity is a key consideration for patients with devices and their physicians.
"As patients live longer, increased device longevity can translate to fewer replacement procedures and a lower risk of complications," Markides added.
"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 labeling 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 added.