The revised product labelings of Boston Scientific's Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) have been cleared by the US Food and Drug Administration (FDA).
Boston Scientific cardiac rhythm management group chief medical officer Kenneth Stein said the new labeling for the company’s US defibrillator products provides doctors and patients with additional assurance about the longevity and reliability of these devices.
"Boston Scientific ICDs and CRT-Ds benefit from our proprietary advanced battery technology," Stein added.
"The new battery was first introduced in the COGNIS and TELIGEN devices in 2008 and has now been incorporated into our newest devices with up to a 10-year warranty."
The company said the longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings.
University of Washington Medical Center arrhythmia service and electrophysiology laboratory director Jeanne Poole said particularly in New York Heart Association Class II patients, it appears that an ICD may prolong a patient’s life for at least a decade by rescuing the patient from sudden cardiac death.
"By helping to mitigate the frequency of replacing an ICD or CRT-D device, this technology provides us with the potential to reduce the complications associated with replacement procedures and to reduce healthcare costs," Poole added.