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.
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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
), which carry a Zacks Rank #1 (Strong Buy), appear