) has published the final results of the Pipeline for Uncoilable
or Failed Aneurysms clinical study, designed to analyze its
Pipeline Embolization device. The results have been published in
the Radiology journal. The device is used for treating adults
with large, giant and wide-neck cerebral aneurysms (a brain
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Cerebral aneurysms is a condition manifested by the dilation of
blood vessels in the brain due to weakness in the wall of a
cerebral artery/vein. According to the National Institute of
Neurological Disorders and Stroke ("NINDS"), it is mostly
prevalent in people aged between 30 and 60 years.
If left untreated, the bulging vessel can put pressure on the
surrounding brain tissues/nerves or may leak or rupture,
resulting in brain hemorrhage. Ruptured cerebral aneurysms affect
roughly 30,000 Americans each year.
Currently, surgery and endovascular treatments are widely used to
treat cerebral aneurysms. However, these are associated with
risks such as potential damage to surrounding blood vessels,
disease recurrence and post-operative stroke. As such, there
remains a major unmet medical need for the treatment of cerebral
The Pipeline Embolization Device, following its implantation,
works by diverting blood flow from an aneurysm. Based on the
clinical study results, this device appears to be a safe and
effective alternative to the existing treatment options for
treating cerebral aneurysms. It was found that of the 106 cases
treated with the Pipeline devices, 73.6% of the aneurysms
completely closed out. Moreover, it had met the trial's
preliminary end points, which led to the U.S. Food and Drug
Administration (FDA) approval in Apr 2011.
Covidien obtained the Pipeline Embolization Device following its
$2.6 billion acquisition of endovascular devices maker, ev3 Inc
in Jul 2010. The device has CE Mark approval in Europe and has
been marketed outside the U.S. since Jul 2009.
Covidien remains committed to rolling out new products and
technologies, focusing on emerging markets, and boosting market
share in the core segments through acquisitions. The encouraging
clinical data should boost sales of the Pipeline devices, which
is a part of the company's Vascular products line under the
larger Medical Devices segment.
Vascular product sales grew 4% to $404 million in the last
reported quarter, backed by solid growth across neurovascular,
peripheral vascular and chronic venous insufficiency offerings,
offset by depressed compression products sale.
However, the company recently provided a dismal fiscal 2013
guidance, which complements its Zacks Rank #5 (Strong Sell).
Further, uncertainty regarding divestment of the Pharmaceutical
unit at the end of the company's third fiscal quarter of 2013,
keeps us on the sidelines.
While we strongly recommend investors to avoid this stock, other
medical stocks such as
) warrant a look. HAE carries a Zacks Rank #1(Strong Buy), while
the other two stocks carry a Zacks Rank #2 (Buy).