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St. Jude Medical wins CE Mark for MRI-safe pacemaker

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St. Jude Medical

St. Jude Medical Inc. (NYSE:STJ) won CE Mark approval for its MRI-safe Accent pacemaker and Tendril lead, gaining on the lead its Twin Cities competitor Medtronic (NYSE:MDT) established with its Revo MRI-safe system.

At least one analyst believes the news puts St. Jude right behind Medtronic and ahead of Boston Scietnific (NYSE:BSX) and its Ingenio entry into the MRI-safe cardiac rhythm management space.

Medronic’s device won pre-market approval from the FDA in early February (the Revo has been on the market in Europe since November 2008, when it won CE Mark as the EnRhythm MRI SureScan system). But the St. Jude device is designed to compete with Medtronic’s second-generation Advisa device, which has also won a nod from European regulators but is not yet on the market in the U.S.

"We checked in with STJ and it appears that the features of STJ’s system are comparable to MDT’s second-generation MRI-safe device (Advisa) still only available in Europe," wrote Rick Wise of Leerink Swann in a note to investors. "Therefore, for U.S. approval, we are inclined to think that this could possibly set STJ on a timeline that is tracking MDT for second-generation technology and is certainly ahead of BSX. The MRI-safe pacemaker will also nicely complement STJ’s increasingly differentiated product portfolio in Europe, which already includes the quadripolar lead and last year’s smaller/more powerful Unify/Fortify systems."

STJ shares were down 3.2 percent to $51.25 in mid-day trading.

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