Boston Scientific announced on 15 April 2010 that it has received FDA clearance for the two validated manufacturing changes affecting all of its cardiac resynchronisation 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 15 and 16 March 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 US.
The company’s pacemakers and other products were not affected by the ship hold and product removal actions. Geographies outside the United States were never affected – and remain unaffected – by these actions.
The company is evaluating the impact of the ship hold and product removal actions on its financial results and will provide an update with the release of its first quarter earnings. These recent actions may have a material impact on the company’s previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010.