US-based medical device firm St. Jude Medical has received CE mark approval for expanded labelling of its Ellipse implantable cardioverter defibrillator (ICD), in addition to the Durata and Optisure defibrillation leads.
With this approval, the devices can be used by patients to undergo magnetic resonance imaging (MRI) scans.
The company has also obtained CE mark approval for its Assurity MRI and Endurity MRI pacemaker device families.
St. Jude Medical group president Dr Eric Fain said: "St. Jude Medical is committed to providing MRI-compatible solutions for its ICD and pacemaker devices for patients and physicians worldwide.
"These products are already proven cardiac rhythm management technologies and now, due to extensive research and testing, they are available in the MRI environment."
Ellipse device uses DynamicTx algorithm that automatically adjusts shocking configurations for patients, as well as DeFT Response technology that allows physicians to customize the amount of energy delivered for each individual patient.
The Assurity MRI and Endurity MRI devices help in early notification of atrial fibrillation-related events and pacing, allowing to reduce heart failure-related hospitalizations.
The company noted that it is planning updated labeling for many of its existing cardiac rhythm management devices, including the Fortify Assura ICD, Quadra Assura CRT-D, and Quartet LV leads.
Image: CE Mark approval of expanded labelling for the Ellipse ICD allows existing and future patients with this technology to undergo MRI scans. Photo: courtesy of Business Wire.