Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of new software for VITALITY AVT and CONTAK RENEWAL 3 AVT & 4 AVT families.
Physician and patient communications
Boston Scientific Corporation has received FDA approval of the ACUITY® Steerable left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.
This product features a deflectable tip for precise placement of the lead even in difficult-to-access branch vessels on the left side of the heart.
Read April 17, 2007 Press Release
Boston Scientific CRM has resolved the deficiencies in the warning letter issued by the FDA to Guidant on December 22, 2005, and all associated restrictions have been removed. The improvements made to our quality system demonstrate our ongoing commitment to deliver the highest quality products to physicians and the patients they serve.
Read April 16, 2007 Press Release
Boston Scientific demonstrates its commitment to ongoing and diligent adverse event reporting by providing the MDR index web-based reference tool, making Medical Device Reports useful and easy to access. The MDR index is located on the Product Performance Resource Center page.
*VITALITY AVT and CONTAK RENEWAL 3 AVT & 4 AVT are not available in all geographies.
Published May 17, 2007 (Revised May 31, 2007)
