) revealed that U.S. Food and Drug Administration (FDA) approved
its micro catheter Apollo Onyx, which is capable of mitigating the
challenges of catheter retrieval during Onyx LES embolizations of
brain arteriovenous malformations (bAVMs). Apollo Onyx is the first
detachable tip micro catheter available in the U.S.
A bAVM is an abnormal connection between arteries and veins
acquired during fetal development. It occurs mainly in the brain or
spine due to a tangle of abnormal arteries and veins. As per
American Heart Association, roughly one in 200-500 people (mostly
males) suffer from bAVMs.
Covidien's Apollo Onyx micro catheter helps physicians choose the
best catheter position for each procedure. The catheter provides
optimal navigability through complex distal anatomy as well as a
proprietary detachable tip designed for easier catheter retrieval
in challenging procedures.
Covidien will showcase the Apollo Onyx micro catheter at the
Society of NeuroInterventional Surgery's (SNIS) 11th annual
meeting. The SNIS meeting will be held in Colorado Springs, CO on
Recently, FDA lowered the risk profile of PillCam endoscopic
camera, produced by the company's subsidiary Given Imaging. Given
Imaging had sent a petition for the downgrade in Nov 2012.
FDA has now classified the PillCam device as Class II device. This
lowers the reviewing criteria of the device from the premarket
approval to the 510(k) premarket notification process. Previously,
FDA has allowed Given Imaging to sell the device only as a back-up
for patients who are incapable for a complete colonoscopy through
Given Imaging's PillCam is a capsule endoscope capable of capturing
image of the digestive system when it is ingested. Per FDA, risks
associated with the device include tissue reactions, failure to
excrete the device, equipment malfunction and abdominal pain,
nausea, vomiting, and choking.
Covidien posted a 3.2% rise in fiscal 2014-second quarter adjusted
earnings per share to 96 cents from 93 cents a year ago, beating
the Zacks Consensus Estimate by a penny. The marginal rise in
earnings was attributable to adverse impacts from foreign exchange
movements and the medical device excise tax. Net earnings, however,
fell 2.2% to $435 million from $445 million due to decrease in
weighted average shares outstanding.
Total revenues in the quarter grew 2.7% to $2,598 million, missing
the Zacks Consensus Estimate of $2,610 million. On a geographic
basis, revenues in the U.S. market increased 1.6% to $1,277
million. On the other hand, revenues from non-U.S. developed
markets rose 1.8% to $938 million and from emerging markets went up
8.8% to $383 million.
Covidien reiterated its revenues outlook for fiscal 2014.
Previously, Covidien had revealed that it expects revenues to grow
2-5% year over year at constant exchange rate for fiscal 2014.
Currently, Covidien carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the medical products industry that are also
worth considering include
Eagle Pharmaceuticals Inc.
). All of them carry a Zacks Rank #2 (Buy).
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