Defibrillators

facilities has locked the company out of applying for approval of its next-gen stent, Taxus Liberte.

Given all the problems at Boston Scientific these days, good news like this - which really amounts to table scraps – is enough to lift the stock substantially.

This could be because the company is at a relative floor, as we postulated in our break-up value analysis of BSX back in February.

Still within a dollar of its 52-week lows, BSX stock has been stifled by data from a recent stent study, called “COURAGE”, which failed to prove that drug-coated stents could decrease the rates of heart attack and death by more than 20% compared with drug therapies.

This study and others have contributed to market share losses in excess of 25% for the drug-eluting stents as a group.

Meanwhile, competitor Abbott Laboratories (ABT)’s new Xience stent is poised to take more share from BSX’s leading Taxus product in the U.S.

and Europe, as new clinical data stated that Xience outperformed Taxus with fewer complications.

Adding insult to injury, the Xience product was sold to Abbott by Boston Scientific as a prerequisite to the Guidant acquisition; under an existing agreement BSX will be able to market the Xience product (which will be sold as “Promus”), but it will be a margin killer as 40% of gross ...

on December 22, 2005; Boston Scientific acquired Guidant last year.

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The one that is still pending, dating from January 2006, involves problems with systems to detect and respond to potentially defective and unsafe products other than so-called heart rhythm devices.

The quality-control warning that's now lifted dates to December 2005, when regulators cited manufacturing and record-keeping problems at a plant in St.

Paul, Minn.

The company, based in Natick, Mass., acquired that plant in April 2006 when it bought Guidant Corp.

for $27 billion.

The 2005 warning prompted Boston Scientific to revamp systems to detect product defects and other problems.

The FDA re-inspected the plant last November and again in December, and found no problems, the company said.

"The principal benefit will be to allow new CRM (cardiac rhythm management) products to be considered for approval," said Paul Donovan, a spokesman for Boston Scientific.

The decision also means Boston Scientific is eligible to receive certificates needed to conduct overseas marketing for devices made at the St.

Paul facility.

The warning at the St.

Paul plant did not hold up any major new product approvals involving Guidant's line of