June 8, 2012 — The U.S. Food and Drug Administration (FDA) has approved revised product labeling for Boston Scientific Corp.’s Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA 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 and approaches eight years for its CRT-D devices. The company backs these devices with warranties of up to 10 years* in the U.S. and many other international markets. Depending on the model, the device warranties are also up to twice as long as other currently marketed comparable devices.
"We're pleased with the new labeling for our U.S. defibrillator products which provides doctors and patients with additional assurance about the longevity and reliability of these devices," said Kenneth Stein, M.D., chief medical officer of Boston Scientific's Cardiac Rhythm Management Group. "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 with up to a 10-year warranty."
"The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) long-term follow-up study results, which were recently presented at the Heart Rhythm Society annual meeting in Boston, demonstrates that ICD therapy continues to benefit patients for a median follow-up of 11 years. Particularly in 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," said Jeanne Poole, M.D., director, Arrhythmia Service and Electrophysiology Laboratory at the University of Washington Medical Center in Seattle.
"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. Not only does the patient benefit from fewer surgeries, but the financial benefit can be significant," said Poole.
For more information: www.bostonscientific.com
* Incepta and Energen VR ICD: 10 years; Incept and Energen DR ICD: 8 years; Punctua and Teligen ICD: 7 years; Incepta and Energen CRT-D: 6 years; Punctua and Cognis CRT-D: 5 years.