Summary
Boston Scientific Corporation (BSX) announced on April 15, 2010, that it has received U.S. Food and Drug Administration (FDA) clearance for two validated manufacturing changes impacting its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs). This clearance allows for the immediate resumption of distribution for their COGNIS CRT-Ds and TELIGEN ICDs, which account for nearly all of their defibrillator implant volume in the United States. The company is prepared to meet customer demand for these products within 24 hours. Furthermore, BSX is actively working with the FDA to secure clearances for earlier generations of these devices, including CONFIENT, LIVIAN, PRIZM, RENEWAL, and VITALITY, which were also subject to an internal review. This review identified additional instances of improper documentation for validated manufacturing changes. While these older products are currently available outside the U.S., BSX aims to return them to the U.S. market as soon as possible. Importantly, the company stated that its pacemakers and other product lines were not affected by these actions, and operations outside the United States remained unimpeded.
Key Highlights
- 1FDA clearance received for manufacturing changes affecting CRT-Ds and ICDs.
- 2Distribution of COGNIS CRT-Ds and TELIGEN ICDs immediately resumes in the U.S.
- 3COGNIS and TELIGEN represent almost all of BSX's U.S. defibrillator implant volume.
- 4BSX is working to clear earlier generation CRT-D and ICD products (CONFIENT, LIVIAN, PRIZM, RENEWAL, VITALITY) for U.S. market return.
- 5Internal review identified additional documentation issues with older product lines.
- 6Pacemakers and other BSX products were not impacted by the ship hold or removal actions.
- 7Operations and product availability outside the United States were unaffected.