CE Mark and European Launch for Medtronic's Evera MRI - Analyst Blog

Medical device major Medtronic, Inc. MDT recently won CE Mark approval for its Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System. With the approval, this system has become the world's first endorsed ICD that also allows full-body magnetic resonance imaging (MRI) scans.

Close on the heels of the approval, Medtronic also announced an immediate European launch of this product. Evera MRI SureScan ICD is yet to get the U.S. approval.

Evera MRI also includes Medtronic's shock reduction algorithm SmartShock 2.0.  According to the company, this will help Evera MRI to better differentiate between dangerous and harmless heart rhythms. Evera MRI also includes OptiVol 2.0 Fluid Status Monitoring and complete diagnostics, that will help identify patients at risk of worsening heart failure and atrial fibrillation.

Compared to other ICDs available, the Evera MRI system gives patients the most unrestricted access to MRI scans. According to recent data, 63% of debilitating heart rhythm disorder patients, who have undergone ICD implantation, also needs an MRI within 10 years of being administered the device. Thus the Evera MRI System, which exactly supports the situation, is expected to create a solid foothold in the wide European ICD market.

After several quarters of drag in sales, management at Medtronic recently confirmed that both the global and core ICD markets are gradually stabilizing. This would result in easier comparisons and should improve growth over the coming quarters.

More significantly, in the last reported quarter, ICD revenue growth was 1% at CER compared to low single-digit market growth rate (both in the global and U.S. ICD markets). ICD growth was primarily due to the strong adoption of the Viva XT CRT-D that drove improvement in Western Europe and Japan. Both Viva and Evera's shock reduction algorithms, including Medtronic's proprietary lead integrity alert, were approved by the U.S. Food and Drug Administration (FDA) recently for monitoring the company's competitors' defibrillation leads.

Moreover, with a 50 basis point-gain in international share and a loss of 50 basis points in U.S. share, global ICD shares remained stable during the quarter. Added to that, the company encouragingly noted that despite a downward trend in the European ICD market due to deteriorating pricing in some key markets, it successfully gained share in this region. With the latest CE mark approval for Evera MRI, we expect continued acceptance and future growth from the Evera family of ICDs.

Currently, Medtronic carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader healthcare industry are Enzymotec Ltd. ENZY, St. Jude Medical Inc. STJ and Covidien plc COV. Enzymotec sports a Zacks Rank #1 (Strong Buy) while St. Jude Medical and Covidien carry a Zacks Rank #2 (Buy).