A St. Jude Medical,
Inc.(NYSE:STJ) Medical facility was being inspected by federal officials. They
had submitted a report of the probe on Tuesday. The report has found significant
flaws in the testing and oversight of the company associated to a controversial
heart device component. The report is likely to raise questions on how St. Jude
executives have recently explained the contents of the inspection to
shareholders and others.
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The report submitted by
FDA focuses on the way the company has handled a product, Durata, which is a
crucial electrical wire connecting an implanted defibrillator to the heart of a
patient. St. Jude reportedly used a material, Optim to insulate the component
and safeguard its electrical veracity. However, there are several questions
that are being raised about the reliability of Optim.
It was in October when
St. Jude had filed a version of the probe report with the Securities and
Exchange Commission but it had blacked out a number of portions of the report
that were about Durata. At that time, the company had said that it was
redacting the information that was based on elucidation of good faith.
However, the FDA did
not leave out the names of the products while releasing the report.
A spokeswoman of St.
Jude, Amy Jo Meyer said that none of the observations in the inspection report
were realized as a particular issue relating to the clinical performance of any
product of St. Jude. She mentioned that the company would not be commenting on
the matter since company communications with regulatory bodies are top secret
with a few exceptions.
The company has been
under the radar for months because of its tackling with issues with a previous
lead sold by the company, named Riata that was failing in a number of patients.
The company had ceased selling that lead in the year 2010; however, it is believed
to be implanted in nearly 1`28,000 patients worldwide.
Shares of the company
slumped 12.15% in Wednesday’s session.
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