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Reading Abbott’s FDA Approval for MR-Conditional Labeling for Its Ellipse ICD


Oct. 3 2017, Updated 9:10 a.m. ET

FDA approval for MRI-compatibility of Ellipse ICD

On September 22, 2017, Abbott Laboratories (ABT) announced the FDA (US Food and Drug Administration) approval of the MR-conditional labeling for its Ellipse ICD (implantable cardioverter defibrillators) with Tendril MRI pacing leads and Durata and Optisure high voltage leads.

Abbott Laboratories aims to accelerate the growth of its ICD market share with the MRI compatibility of its Ellipse ICD. The approval should allow the patients with the Ellipse ICD implants to undergo MRI scans.

Notably, Abbott Laboratories faces stiff competition in the MRI-Compatible ICD market from major medical device players including Medtronic (MDT), Boston Scientific (BSX), and Edwards Lifesciences (EW).

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What is Ellipse ICD?

The Ellipse ICD was acquired by Abbott Laboratories through the acquisition of St. Jude Medical in January 2017. The device is used to monitor heart rhythms of patients suffering from ventricular tachycardia, or unusually fast heart rhythms. ICDs provide electrical pulses to patients’ hearts to enable natural heart rhythms.

Some of the key features of the Ellipse ICD include the DeFT Response Technology, SecureSense, and DynamicTx. The DeFT Response Technology enables the delivery of successful patient-specific therapy, while the SecureSense algorithm provides protection to patients against unnecessary therapy delivery. The DynamixTx algorithm enables consistent evaluation of the lead condition and appropriate therapy delivery through electrical impulses.

Notably, investors interested in gaining exposure to Abbott Laboratories can invest in the iShares Core S&P 500 ETF (IVV), which has ~0.43% of its total holdings in ABT.


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