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St Jude Medical’s MRI-compatible pacing technology receives CE Mark
St Jude Medical has announced that a label update for its Tendril STS and IsoFlex Optim pacing leads has been approved in Europe.
The CE Mark approval allows existing and future patients using the leads to access magnetic resonance imaging (MRI) scans, when used with the Accent MRI pacemaker.
Both products utilise the Optim insulation material, a hybrid insulation material that blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane.
They were originally designed to be used in an MRI environment and have demonstrated proven reliability, with a survivability rate of more than 99 percent.
Dr Eric Fain, group president of St Jude Medical, said: "St Jude Medical is committed to providing MRI-compatible pacing solutions to patients and physicians around the world. We believe many patients can benefit from pacing therapies with MRI scanning capabilities when they have additional health concerns."
This comes after the firm reported data from a study earlier this month showing the benefits of its FFR technology in treating non-ST segment elevation myocardial infarction heart attacks.
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