"This brings us an important step closer to approval of the TAXUS system in the U.S.," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "I want to congratulate our Maple Grove team for this flawless inspection. I am very proud that the FDA inspectors reported no observations at Maple Grove or Galway. This further demonstrates our commitment to quality in every aspect of the TAXUS program. Based on these two outstanding inspections, I am confident the FDA will approve the TAXUS system this quarter."
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and introduction, clinical trials, regulatory approvals, competitive offerings, litigation, operational improvements, the Company's overall business strategy, and other factors described in the Company's filings with the Securities and Exchange Commission.