FDA Sets New Stent Guidelines

For Boston Scientific (BSX) the news gets worse every day. The FDA says it will set up new guidelines for testing stents, which is one of BSX’s largest businesses. According to The Wall Street Journal "the new FDA guidelines, which are expected to be more stringent than those currently in force, will probably cover items such as the numbers of patients on whom new stents must be tested and for how long"

The new government rules should not effect stents which are already on the market, but as companies like BSX begin to test new generations of the products, the fence they will have to clear may be much higher. And, the announcement is not likely to ease the concerns of doctors and patients who have seen studies that drug-coated stents can cause clotting.

BSX sold off two of its business units to a private equity firm yesterday. The company got $425 million. But, with $7.9 billion in debt, there will be more sales of businesses.

With market trends hurting its most important business, Boston Scientific will have to become a much smaller company to survive.

Douglas A. McIntyre