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Medtronic's (MDT) MRI CRT-D Device Gains FDA Approval

MDT BAX NXTM BVX

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Medical device maker Medtronic plc (MDT - Free Report) recently announced the receipt of FDA approval for its Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for the treatment of heart failure. The MRI CRT-D device has been approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines. It also features EffectivCRT, a new algorithm that automatically adjusts pacing rates to meet individual patient needs.

To date, CRT devices have been used to just send a pacing pulse but it was hard to determine whether the stimulation actually improved the heart`s pumping ability. A number of heart failure patients receiving CRT have atrial fibrillation (AF) which can drastically reduce patient’s response to CRT. The Claria device offers the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace and the EffectivCRT during AF algorithm, which adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additionally, the Claria device features adaptivCRT algorithm which reduces AF risk, automated VectorExpress test, Attain Perfoma MRI SureScan Quadripolar Leads to reduce phrenic nerve stimulation occurrenceand SureScan MR-conditional labeling for full-body scans without positioning restrictions.

Management claims that its latest innovation sets a new level of personalized care and aims to improve patients` response to CRT. The FDA approval also expands Medtronic’s MR-conditional portfolio of devices. In addition to introducing CRT to the worldwide marketplace nearly 20 years ago and offering the first MR-conditional CRT-defibrillators in the U.S., the Medtronic heart failure portfolio includes mechanical circulatory support therapy and impactful heart failure diagnostics and expert analysis through Medtronic Care Management Services.

Medtronic has also submitted a Pre-Market Application (PMA) with the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds. The Multiple Point Pacing feature is not presently approved for commercial sale in the U.S.

As per a MarketsandMarkets report, the global MRI systems market is forecasted to reach a worth of $7.19 billion by 2021 from $5.61 billion in 2016, at a CAGR of 5.1% from 2016 to 2021. We can say that Medtronic is striving to capture the untapped potential of this growing market. In the last reported quarter, Medtronic’s Cardiac and vascular group performed well and grew in mid-single digits. We expect that the FDA approval of the Claria device to further boost the segment.

Zacks Rank & Key Picks

Medtronic currently carries a Zacks Rank #3 (Hold). Better-ranked medical stocks are Nxstage Medical Inc. (NXTM - Free Report) , Baxter International Inc. (BAX - Free Report) and Bovie Medical Corporation (BVX - Free Report) . Nxstage Medical and Baxter sport a Zacks Rank #1 (Strong Buy) while Bovie Medical carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Nxstage Medical surged 34.2% over one year compared to the S&P 500’s 6.9% over the same period. The company has a four-quarter positive average earnings surprise of 50.00%.

Baxter international rallied 24.6% in the past one year, comparing favorably with the S&P 500’s 6.9%. It has a trailing four-quarter average positive earnings surprise of 27%.

Bovie Medical recorded a 103.6% gain in the past one year, way better than the S&P 500’s 6.9%. The company has a trailing four-quarter positive average earnings surprise of 28.7%.

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