| CHICAGO, April 9
CHICAGO, April 9 Shares of St Jude Medical Inc
fell nearly 5 percent on Monday on concerns that a
drumbeat of negative news about its heart rhythm products will
hurt sales of the medical device company's main franchise.
St Jude on Friday called on a medical journal to retract an
article about patient deaths associated with its Riata
defibrillator leads, saying the manuscript contained errors and
biased analysis. Leads are insulated wires that connect
implanted cardioverter defibrillators (ICDs) to the heart.
The article in the journal HeartRhythm concluded that St
Jude's Riata and Riata ST leads are prone to failures that have
led to deaths. Although the article was published March 26, St
Jude's call for a retraction drew attention to the article only
days after the company said it was halting sales of two other
types of leads.
Investors feared that more scrutiny of the company's leads
ultimately could hurt sales, said Jefferies analyst Raj Denhoy.
"The concern is that this could have a chilling effect on
the company's ICD sales," Denhoy said.
The article's author, Dr. Robert Hauser of the Minneapolis
Heart Institute Foundation, examined deaths reported in a U.S.
Food and Drug Administration database.
"These failures appeared to be caused by insulation defects
that resulted in short-circuiting between high-voltage
components," Hauser wrote.
Hauser's team also looked at deaths associated with
Medtronic Inc's Quattro Secure leads, and found fewer
deaths linked to that product.
St Jude, in a press release, said its own analysis of the
FDA database could not reproduce the numbers reported in the
HeartRhythm article. The company also criticized the use of the
database to evaluate rates of adverse events and to compare
A spokeswoman for the Heart Rhythm Society, publisher of the
HeartRhythm journal, could not be reached for comment on St
Jude's request for a retraction.
St Jude, which stopped selling the Riata leads in December
2010, last November advised doctors that the leads have a higher
rate of insulation failures than initially reported. The company
advised against removing or replacing the leads.
The company said it had reports that two patients had died
and one had suffered a serious injury during procedures to
remove the leads.
FDA subsequently classified St Jude's advisory as a recall.
Last week, St Jude halted sales of two more brands of lead
wires used in its cardiac resynchronization therapy devices due
to worn insulation. Those products, the QuickSite and QuickFlex
leads, connect to the heart a device that uses a specialized
pacemaker to re-coordinate the action of the right and left
ventricles in patients with congestive heart failure.
"St Jude shares will likely remain under pressure as
investors remain anxious about the possibility of more negative
lead news," Leerink Swann analyst Rick Wise wrote in a note to
St Jude shares fell $1.97, or 4.8 percent, to $39.00 in
afternoon trading on the New York Stock Exchange.