By Tess Stynes
St. Jude Medical Inc. (STJ) said the U.S. Food and Drug
Administration granted approvals for three of the medical device
maker's pacemakers including its Allure Quadra.
"In international markets where the Allure Quadra CRT pacemaker
is available, we experience strong demand and significant share
capture as the technology has become the standard of care for many
physicians," said Eric S. Fain, group president.
Quadripolar technologies offer additional options for physicians
to treat heart-pacing complications without additional surgery.
The company also said the FDA approved its Assurity pacemaker
and Endurity pacemaker families of devices.
The pacemakers received approval from European regulators in
March 2013. St. Jude plans to launch the devices by the end of the
first quarter.
St. Jude has struggled against industrywide pressures, including
pricing pressures from hospitals and insurers, in addition to
regulatory and legal scrutiny of the frequency and necessity of
some surgeries. St. Jude has faced its own share of problems as
well, including controversy over the durability and safety of the
wires, or leads, used to connect its defibrillators to patients'
hearts.
Write to Tess Stynes at tess.stynes@wsj.com
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