NATICK, Mass. (AP) -- Boston Scientific said Wednesday the Food and Drug Administration has lifted some restrictions imposed more than two years due to quality control problems.
In 2006 the FDA issued the company a rare "corporate warning letter," which barred the approval of significant new products. Boston Scientific Chief Executive Jim Tobin said the agency has lifted the ban on product approvals. The formal letter remains in place due to issues surrounding the company's reporting of complaints and malfunctions of its devices.
Tobin told analysts on an earnings call that the company was actively working to resolve those issues.
Many analysts have previously suggested the company was making progress toward resolving FDA's complaints. Earlier this month FDA approved the company's next-generation Taxus Liberte stent, which was launched in Europe in 2005 but had been delayed by the warnings letter.
On Tuesday Boston Scientific reported that sales of its heart-shocking implants helped partially offset lower sales of drug-coated stents. Adjusted to exclude one-time charges, earnings were $236 million, or 16 cents per share, down from $299 million, or 20 cents per share.
The company said revenue fell to $1.98 billion from $2 billion in the same period last year.
In recent weeks Boston Scientific's stock has been hammered by involuntary trading triggered by turbulence in the financial market. RBC Capital Markets analyst Phil Nabone stated that shares are likely to see a boost.
"Although there has been no meaningful change in the fundamental profile, we expect the stock to enjoy a bit of a 'relief rally' off of the artificial lows of recent weeks," Nabone wrote in a note to investors.
Shares of Boston Scientific rose 5 cents to $8.68 in morning trading.
