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Medtronic's Advisa, Ensura Pacemakers Win CE Mark (Revised) - Analyst Blog

Medtronic, Inc. ( MDT ) recently reported the receipt of CE (Conformité Européenne) Mark and the subsequent commercial launch of its Advisa and Ensura SR MRI SureScan single chamber pacemaker devices in Europe.

However, the news had no significant impact on Medtronic's share price which remained essentially unchanged at $61.02 at market close on Monday.

Magnetic resonance imaging, or MRI, is the standard procedure in soft tissue imaging. It provides information that cannot be otherwise seen through X-ray, ultrasound or CT scan, and refrains from exposing patients to ionizing radiation.

Advisa and Ensura SR MRI pacemakers provide single chamber pacing engineered with the same SureScan technology used in other Medtronic MR-Conditional pacemakers and implantable cardioverter-defibrillators (ICDs). Additional features include improved diagnostic information and storage as well as a 35% improvement in battery longevity.

Both the pacemakers have been approved for MRI scans positioned on any region of the human body. However, these devices are yet to be sanctioned for use in the U.S.

Prior to the approval of MR-conditional pacemakers, patients with these implanted devices were not allowed to undergo MRI procedures because of the risk of harmful interaction between the devices and the MRI scanner. Roughly 50-75% of the patients with an implanted pacemaker are estimated to be in the need of an MRI scan over the lifetime of their device.

Reliable sources suggest that for patients with chronic atrial fibrillation and intermittent AV block, physicians can administer better treatment options to those implanted with Advisa or Ensura MRI single chamber pacemakers.

Single-chamber pacemaker patients in Europe will now have the option to select from among two commercially available devices that will enable them to have full-body MRI access with no scanning or positioning restrictions.

At present, Medtronic is the only company that produces the U.S. Food and Drug Administration (FDA) approved pacemaker system for MRI scans positioned on any region of the body. Alongside, it also offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

The Advisa and Ensura single chamber pacemakers are the latest additions to an increasing line of Medtronic devices that are designed for MRI access including the Advisa MRI and Revo MRI dual chamber SureScan pacing systems, the Reveal LINQ Insertable Cardiac Monitoring (ICM) system and the SynchroMed II programmable drug infusion system which are available all over the world.

Medtronic currently has a Zacks Rank #3 (Hold).

Other better-ranked Medical Products stocks that warrant a look include Cardica Inc. ( CRDC ), Exactech Inc. ( EXAC ) and NeuroMetrix Inc. ( NURO ). All these stocks carry a Zacks Rank #2 (Buy).

(We are reissuing this article to correct a mistake. The original article, issued on June 4, 2014, should no longer be relied upon.)

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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