Boston’s Defibrillators: CE Approval For Extended Longevity Means Fewer Interventions

In short

Boston Scientific Corporation 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.


According to Boston Scientific’s blurb on the subject, more than 40% of ICD-implanted patients are surviving more than ten years, which it says justifies the argument for using devices with the maximum possible useful life.  Indeed projected device longevity for some models of Boston Scientific ICDs exceeds ten years and approaches eight years for its CRT-D devices. Boston says these figures are up to double that of comparable competitive device models. The company supports these devices with extended warranties, varying from five years for the Punctua and Cognis CRT-D devices, to ten years for Incepta and Energen VR ICD’s.

Now the CE mark approval for the family of devices includes these longer lifetimes, enabling the company to label them as such.

Physician comments

“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.”

Company comments

“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.”

Source: Boston Scientific Corporation