CHICAGO, April 9 Medtronic Inc said on
Monday it agreed with research findings that favored the medical
device maker's Sprint Quattro heart defibrillator lead over a
rival product by St Jude Medical Inc.
St Jude on Friday urged medical journal HeartRhythm to
retract an article on the research written by Dr. Robert Hauser
of the Minneapolis Heart Institute Foundation.
Hauser had analyzed data on lead failures and death rates
for St Jude's Riata and Riata ST defibrillator leads - which
were discontinued in December 2010 because of insulation
problems - and Medtronic's Quattro leads.
He concluded that St Jude's leads, which are insulated wires
that connect an implanted defibrillator to the heart, were prone
to failures that led to deaths. Fewer deaths were linked to the
Medtronic lead, he said, based on data from the U.S. Food and
Drug Administration's MAUDE database.
St Jude said Hauser's analysis undercounted reports of
deaths involving Medtronic's Quattro leads.
Medtronic, however, said it reviewed the data on Quattro,
following criteria outlined in Hauser's article.
"The conclusions we have reached about Sprint Quattro are
consistent with what Dr. Hauser found, and we confirm his
results related to Sprint Quattro," Medtronic said in a
statement emailed to Reuters.
Hauser said the St Jude lead failures appeared to be caused
by insulation defects that resulted in short-circuiting between
St Jude, in a press release Friday, 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 informed doctors last November 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.
On the New York Stock Exchange, St Jude fell $2.06, or 5.03
percent, to close at $38.91, and Medtronic ended down 45 cents,
or 1.18 percent, at $37.75.