SOTK 1.10, 14.4 mil. shs. out. and consistently profitable. All of the big medical device makers are introducing next generation drug coated stents which should pave the way for a resurgence of business for SOTK's stent coating equipment line:
J&J's Cordis unit resolves issues with FDA
CHICAGO, June 14 (Reuters) - Johnson & Johnson (JNJ.N: Quote, Profile , Research) on Thursday said its Cordis unit, which makes cardiovascular devices, has resolved its issues with the U.S. Food and Drug Administration, clearing the way for the introduction of new products.
Cordis, best known for its Cypher drug-eluting heart stent, has been operating under a warning from the FDA since April 2004. Regulators cited problems with internal procedures, including many issues with manufacturing processes.
Resolving the issues with the FDA means the company can now launch the next-generation of its Cypher stent, a tiny, tubular device that props open diseased arteries and delivers drugs to the site to prevent the vessels from reclogging.
Cordis' Cypher stent competes in the United States with Boston Scientific's (BSX.N: Quote, Profile , Research) Taxus drug-eluting stent. Medtronic Inc. (MDT.N: Quote, Profile , Research) and Abbott Laboratories (ABT.N: Quote, Profile , Research) are expected to launch similar products in the United States over the next few years.
However, the use of such devices, initially hailed as revolutionary, has declined over the last few quarters amid controversy that they may pose serious risks of deadly blood clots.
And drug-eluting stents, which have been lucrative for the manufacturers, came under fire when a study suggested the devices were no better than standard drug treatments in reducing deaths and heart attacks in patients with minor chest pain.
Miami Lakes, Florida-based Cordis said the penetration of drug-eluting stents, also known as drug-coated stents, was down to the mid-60 percent range as of April from a peak in the mid-80 percent range a few years ago.
J&J shares were up 9 cents to $62.27 while shares of competitor Boston Scientific were up 2 cents to $16.16 in early the New York Stock Exchange trade.
