St Jude Medical has received CE Mark approval for expanded labelling for its Ellipse implantable cardioverter defibrillator (ICD).
The approval enables current or future patients using Ellipse ICD and the previously approved Durata and Optisure defibrillation leads to undergo magnetic resonance imaging (MRI) scans without compromising device performance.
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In addition, the company secured CE Mark approval for its Assurity MRI and Endurity MRI pacemaker device families, which further expand its MRI-conditional device portfolio in Europe.
St Jude Medical group president Eric Fain said: "These products are already proven cardiac rhythm management technologies and now, due to extensive research and testing, they are available in the MRI environment.
"We will continue to develop advanced MRI-compatible technologies in order to ensure patient access to this important diagnostic tool."
Leveraging the company’s DynamicTx algorithm and DeFT Response technology, the Ellipse ICD offers enhanced protection to patients in the event of a life-threatening arrhythmia.
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By GlobalDataThe DynamicTx algorithm automatically adjusts shocking configurations for patients to help ensure the delivery of high-voltage therapy if an electrical short occurs in one part of the system.
DeFT Response technology enables physicians to customise the amount of energy delivered for each individual patient, in addition to low friction coating on the device can.
This significantly reduces the friction between the device and leads, reducing lead-to-can abrasion.
Claimed to the world’s smallest, longest-lasting wireless pacemakers available to patients, the Assurity MRI and Endurity MRI devices facilitates early notification of atrial fibrillation-related events and pacing that lowers heart failure-related hospitalisations.
Both pacemakers are supported by the Merlin.net Patient Care Network website for remote patient management.
St Jude Medical expects to secure updated labelling for many of its existing cardiac rhythm management devices in the next few months, which would help more patients safely undergo MRI scans.
The company intends to submit test data in key markets worldwide in 2015 for MRI conditional labelling on additional existing high-voltage products including the Fortify Assura ICD, Quadra Assura CRT-D and Quartet LV leads.
Image: Ellipse ICD offers added protection to patients in the event of a life-threatening arrhythmia. Photo: courtesy of Business Wire.
