Boston Scientific Corporation (NYSE: BSX) today announced that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of its COGNIS® CRT-Ds and TELIGEN® ICDs. The Company is positioned to fully meet customer demand for COGNIS and TELIGEN within 24 hours. COGNIS and TELIGEN represent virtually all of the Company's defibrillator implant volume in the United States.
On March 15th and 16th the Company submitted the two manufacturing changes to the FDA for the following CRT-D and ICD product families: COGNIS, TELIGEN, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL® and VITALITY™. Solely on its own initiative, the Company has conducted an internal review of manufacturing and other changes for these products, as well as the associated regulatory submissions. The review found a few additional instances where the Company did not submit the appropriate documentation for validated manufacturing changes for CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY. The Company has now submitted this documentation and is working closely with the FDA to secure clearances to return CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY -- the earlier generations of the Company's CRT-D and ICD products -- to market as soon as possible in the United States. These products may continue to be implanted in geographies outside the United States.