Boston Scientific has received FDA clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and will immediately resume distribution of Cognis CRT-Ds and Teligen ICDs.
Reportedly, on March 15th and 16th, Boston Scientific has 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, Boston Scientific has conducted an internal review of manufacturing and other changes for these products, as well as the associated regulatory submissions.
Boston Scientific said that the review had 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.
Boston Scientific has submitted the 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 US. The products may continue to be implanted in geographies outside the United States.
Boston Scientific’s pacemakers and other products were not affected by the ship hold and product removal actions. Geographies outside the US were never affected and remain unaffected by the actions.
Ray Elliott, president and chief executive officer of Boston Scientific, said: “We are pleased that the FDA has cleared the manufacturing changes, and that we are again able to offer Cognis and Teligen to US patients and physicians. We are committed to doing the right thing every time, and we acted voluntarily, swiftly and appropriately to ensure compliance with all regulatory requirements.”