Boston Scientific to Immediately Resume Distribution of LIVIAN™, RENEWAL®, VITALITY™, PRIZM™, and CONFIENT™ Defibrillators in the U.S.
Boston Scientific Corporation has sent letters to physicians and patients announcing that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all its LIVIAN™ and RENEWAL® cardiac resynchronization therapy defibrillators (CRT-Ds) and CONFIENT™, PRIZM™ and VITALITY™ implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of these defibrillators.
Previously, on March 15 and 16, Boston Scientific 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™. Two of the devices, COGNIS and TELIGEN, were cleared to resume sales on April 15. The latest action clears the hold on the remaining devices.
