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STJ Presents RESPECT Trial Data

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Medical devices major, St. Jude Medical Inc. , presented additional data from the RESPECT clinical trail at the American Stroke Association’s International Stroke Conference 2013. The trial is analyzing the effectiveness of the Amplatzer PFO Occluder for closing a patent foramen ovale or PFO (an opening in the heart) to prevent recurrent strokes in patients, especially those who had experienced cryptogenic stroke.

Data revealed that patients with the device experienced lesser, smaller strokes that were less likely to originate from blood clots passing through the PFO. This reduces the risk of an ischemic stroke. As per the World Health Organization (WHO), strokes affect approximately 15 million people across the globe every year, rendering it to be one of the leading causes of death and long-term disability.

The Amplatzer PFO Occluder technology from St. Jude’s structural heart devices portfolio uses the minimally-invasive transcatheter technique for PFO closure. The company acquired this technology from AGA Medical Holdings, Inc., which it took over in 2010.  The product received CE Mark approval in 1998.  

Earlier, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Oct 2012, the company released primary data which was hardly statistically significant. However, it trended toward superiority on secondary analysis.

Data indicated that the risk of a stroke was reduced by 46.6% to 72.7% when patients were treated with the Amplatzer PFO Occluder over conventional medical management. Despite missing its primary endpoints, St. Jude plans to submit the product for FDA clearance by mid-2013.

With a market size of $200 million, the Amplatzer PFO closure device represents a major growth driver for St. Jude’s structural heart products business. The franchise grew 3.3% in constant currency in the fourth quarter of 2012. On a constant currency basis, the company expects to record 6%–9% revenue growth in 2013, on the back of a change in sales mix from legacy products to high growth offerings.

The company has a Zacks Rank #3 (Hold). While we remain on the sidelines regarding St. Jude, medical products companies such as Nuvasive Inc. (NUVA), Hanger Inc. and ResMed Inc. (RMD - Free Report) , which carry a Zacks Rank #1 (Strong Buy), appear impressive.

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