|St. Jude Medical scored CE mark approval for three defibrillators, including the Unify CRT-D--courtesy of St. Jude|
And, finally, some good news for St. Jude Medical's ($STJ) cardiac business. The devicemaker won CE marks for three implantable defibrillators whose technology can reduce inappropriate shocks by 74%, the company says.
The Assura family of devices includes the Quadra and Unify CRT-Ds and the Fortify ICD, and St. Jude says it has rejiggered its standard algorithms to make the devices more responsive and less prone to inopportune therapy, all while delivering a highest-available 40 Joules of energy.
Launching the three devices in Europe allows St. Jude to cater to patients' wide-ranging cardiac needs, said Eric Fain, president of the Implantable Electronic Systems Division. "The Assura line of devices was designed for safety, reliability and extended longevity to help physicians best treat their patients," Fain said in a statement.
Of course, while the regulatory win may bolster St. Jude's European cardiac sales, the company still faces major concerns over its leads--the components that deliver energy from implants to hearts. After a profit-sapping recall of Riata leads last year, St. Jude unveiled the re-engineered Durata line, but recent FDA concerns over how the company tests and manufactures the devices have grabbed headlines and cast a shadow over the devicemaker's efforts.
And the worst may be yet to come. Last week, Citi analyst Matthew Dodds told investors that Durata could find itself yanked off the market by mid-2013, presenting an opportunity for competitors such as Boston Scientific ($BSX) and Medtronic ($MDT), but only deepening the hole for St. Jude.
- read the announcement