Boston Scientific Corporation announced that an inspection team from the US Food and Drug Administration (FDA) has completed its inspection of the company's drug-eluting stent manufacturing facility in Maple Grove, Minnesota. The team reported no observations during the inspection and indicated it intends to recommend to the FDA that the Maple Grove facility be approved to manufacture the Taxus Express2 paclitaxel-eluting coronary stent system for the US market. The inspection was the second of two by the FDA of Boston Scientific's drug-eluting stent manufacturing facilities. In January, an FDA team inspected the company's drug-eluting stent manufacturing facility in Galway, Ireland and reported no observations.
"This brings us an important step closer to approval of the Taxus system in the US," said Jim Tobin, CEO 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 programme. Based on these two outstanding inspections, I am confident the FDA will approve the Taxus system this quarter."