Defibrillators

Warning Letter Has No Impact on Boston Scientific Corp.'s Ratings TODAY ON PHARMALIVE.COM S&P: Lifting Of Guidant Corp.

Warning Letter Has No Impact on Boston Scientific Corp.'s Ratings NEW YORK April 16, 2007-Today's lifting of the U.S.

Food and Drug Administration (FDA) warning letter for Boston Scientific Corp.'s (BBB/Negative/A-2) cardiac rhythm management (CRM) facility (originally issued to Guidant Corp.

in December 2005) is a positive development, according to Standard & Poor's Ratings Services.

However, the company still faces the challenge of rebuilding its share of the CRM market in the face of an overall market contraction triggered by the Guidant CRM product recalls in 2005.

Resolution of the warning letter may enhance customer confidence and importantly, will permit Boston Scientific to introduce next-generation CRM products and remain competitive.

Boston Scientific still operates under a corporate-wide FDA warning letter which may impede its ability to introduce the Liberte drug-eluting stent (DES) in the U.S.

This next-generation DES to Taxus is currently sold in Europe.

DES sales and penetration of the stent market (versus bare metal stents) has fallen because of concerns regarding late stent thrombosis.

Boston Scientific is considering asset sales to alleviate its significant debt burden (about $9 billion) given the slowdown in its two key markets.

The outlook on the company remains negative.

Complete ratings in...

Read more...