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Abbott's Ellipse ICD Receives FDA Approval for MRI Scans

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Abbott’s (ABT - Free Report) Ellipse implantable cardioverter defibrillator (ICD) recently gained FDA approval for magnetic resonance (MR) conditional labeling. This should solidify the company’s footprint in the Rhythm Management space.

Post-approval, patients implanted with an Ellipse device and Durata or Optisure leads will be able to undergo MRI scans. Moreover, Ellipse will now be available to patients suffering from severely high heart rhythms and in need of an ICD along with a MRI scan. Thus, we believe that this latest regulatory approval will expand the company’s customer base and drive its top line.

Moreover, Ellipse is embedded with features known as Abbott's TailoredTherapy and is capable of directly, securely and wirelessly forwarding all therapy and related data to a patient's physician through the Merlin.net Patient Care Network.

Continuing with its efforts to expand the MR-conditional labeling enabled devices, the company received FDA approval for MR-conditional labeling for Assurity MRI pacemaker and Tendril MRI pacing lead. Also, the company has received certain prior MR-conditional labeling approvals in Europe.

Meanwhile, Abbott had applied for FDA approval of MRI-conditional labeling for its Quadra Assura Cardiac Resynchronization Therapy Defibrillator (CRT-D) products and Quartet family of left ventricular leads.

Interestingly, the company witnessed softness in its Rhythm Management segment majorly due to tough competition in the MRI-conditional category of products. The market is dominated by some well-established players like Medtronic plc (MDT - Free Report) , Boston Scientific Corporation (BSX - Free Report) and Edwards Lifesciences Corporation (EW - Free Report) , among others.

Abbott’s strategy to gain traction in the Rhythm Management sub-segment seems to be aligned with data provided by Allied Market Research Per the report, the global Cardiac Monitoring and Cardiac Rhythm Management market is expected to see a CAGR of 7.6% from 2016 to 2022 to reach a value of $32,216 million.

We believe that unhealthy lifestyle and a rise in ageing population will continue to result in high incidence of cardiovascular diseases. This is further supported by data provided by GBI Research. Per the report, the global cardiovascular diseases market will see a CAGR of 4.1% by 2019, and within this space, the U.S. market is expected to witness the highest momentum at a CAGR of 4.7%.

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