St Jude Medical has announced CE mark approval of updated labelling for its Tendril STS and IsoFlex Optim pacing leads. The new labelling allows existing and future patients with the devices access to magnetic resonance imaging (MRI) scans. The leads are used with the Accent MRI pacemaker.
The Tendril STS and IsoFlex Optim pacing leads are built on the Tendril and IsoFlex lead platforms, and include St Jude Medical’s Optim insulation material, component that, according to a company release, provides increased durability, improve flexibility, handling characteristics and control during implant procedures.
In addition to this approval, St Jude Medical also announced that it plans to seek updated labelling for many existing products in order to allow patients the ability to safely undergo MRI scans. St Jude Medical plans to submit testing data in Europe, Japan, Australia and the USA for MRI conditional labeling on several additional existing products including the Fortify Assura implantable cardioverter defibrillator (ICD), Ellipse ICD, Quadra Assura cardiac resynchronisation therapy defibrillator (CRT-D), Durata and Optisure defibrillation leads.