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Teleflex Gets 510(k) Clearance for Restated Indications

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Teleflex Incorporated (TFX - Free Report) revealed that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its restated Indications for use of the EZ-IO Vascular Access System. Following the announcement, shares of the company rose 0.1% to close at $104.02 yesterday.

The restated indications will help clinicians to assess the tissue depth and select the correct needle size for treating the patients. For example, the restated indication for the EZ-IO 25 mm Needle Set is recommended for use in patients weighing 3 kg or over. The 15 mm and 45 mm needle sets should be used for patients weighing 3 to 39 kg and 40 kg or over, respectively.

EZ-IO Vascular Access System has been developed by Vidacare Corporation, acquired by Teleflex in Dec last year. Vidacare is a leading provider of intraosseous (IO), or inside the bone access devices.

Teleflex posted an 18.3% rise in adjusted earnings to $1.36 per share for the fourth quarter of 2013 from $1.15 per share in the same quarter of 2012. With this, earnings significantly beat the Zacks Consensus Estimate of $1.27.

Adjusted net earnings rose 22.9% to $58.5 million from $47.6 million in the year-ago quarter.  Following the favorable earnings announcement, shares of the company rose 0.8% till the last closing date.

Net revenues went up 7.5% to $450.5 million, exceeding the Zacks Consensus Estimate of $436 million. Excluding foreign exchange fluctuations, net revenues rose 6.9% from the prior-year quarter.

The increase in revenues was attributable to contribution from the acquisitions of LMA International in Oct 2012 and Vidacare Corporation, an increase in the average selling price of products, launch of new products and an additional shipping day in the reported quarter versus the same quarter of 2012.

For full year 2013, Teleflex reported a 13.5% rise in adjusted earnings to $5.03 per share from $4.43 in 2012. Adjusted net earnings rose 16.1% to $211.6 million from $182.2 million a year ago. Net revenues went up 9.4% to $1,696 million. Excluding foreign exchange fluctuations, net revenues rose 9.0% in the year.

For 2014, Teleflex anticipates revenue growth between 6.0 and 8.0% versus 2013. In constant currency, the company expects revenues to increase by 7.0 to 9.0%.

Teleflex also expects adjusted earnings per share in the range of $5.35 to $5.55 for 2014. The current Zacks Consensus Estimate of $5.51 lies within the guided range.

Currently, Teleflex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical instruments industry include Cynosure, Inc. , Syneron Medical Ltd. , and ABIOMED, Inc. (ABMD - Free Report) . Both Cynosure and Syneron Medical sport a Zacks Rank #1 (Strong Buy), while ABIOMED carries a Zacks Rank #2 (Buy).

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