Abbott won its first FDA approval for a magnetic resonance-conditional labeling for one of its implantable cardioverter defibrillators (ICD), the Ellipse. Additionally, Tendril MRI pacing lead, as well as Durata and Optisure high voltage leads that are compatible with the Ellipse, are also approved to be safe inside an MRI machine as long as certain precautions are taken. This keeps the full gamut of diagnostic options still available to patients getting an Ellipse implant.
The Ellipse, which delivers up to 36 Joules of energy, is already being used by thousands of patients, as it has been on the market for a few years now. The new approval applies to patients previously implanted with the Ellipse and compatible leads. Perhaps some of them can now go get an MRI for a condition that was previously difficult to diagnose, as a magnetic resonance scan was unavailable to them.
Some of the features of the Ellipse ICD, according to Abbott:
- DeFT Response™ Technology: Allows physicians to adapt how therapy is delivered by the Ellipse ICD to ensure each patient receives therapy based on their unique need. The feature also helps ensure successful therapy delivery without the need to deliver an initial shock at the time of implant.
- SecureSense™: Abbott’s SecureSense algorithm offers an additional level of protection for patients by providing proper sensing within the heart even in the presence of external interference (known as “lead noise”) to safeguard against unnecessary therapy being delivered to the patient.
- DynamicTx™: With Abbott’s DynamicTx algorithm, physicians can be confident that their patient’s devices are consistently evaluating the condition of the lead and adapting the path of the electrical impulse to deliver appropriate therapy.
Flashbacks: St. Jude’s Ellipse “Physician-Inspired” ICD Gets Green Light in Europe…; St. Jude Medical’s High Voltage ICD/CRT-Ds Approved in U.S…; St. Jude Gets CE Mark for Ellipse, Assura High Voltage Cardiac Devices…;
Product page: Ellipse ICD…