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FDA Nod for Covidien's Novel Surgical Stapler

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Covidien plc has secured the U.S. Food and Drug Administration’s (FDA) 510(k) approval for Endo GIA Reinforced Reload with Tri-Staple technology. This clearance is a milestone for Covidien that allows it to enter the U.S. market with its industry-leading portfolio of advanced surgical staplers.  

The Tri-Staple platform of stapling products from Covidien is an all-in-one solution that is uniquely designed to address customer needs. The Endo GIA Reinforced Reload combines the benefits of Tri-Staple technology with a pre-attached synthetic, porous buttress material. This particular material, which is a version of NEOVEIL felt developed by GUNZE Ltd., makes the product suitable for additional support to fragile tissue being stapled and resected. NEOVEIL felt has been in clinical use in the Japanese market for more than 20 years.

In addition to better patient outcomes, surgeons will also benefit from the Endo GIA Reinforced Reload as the product promises easier and shorter surgical processes, leading to reduced procedure time.

Recently, Covidien also announced the receipt of the Shonin approval from the Japanese Ministry of Health, Labor and Welfare for the Endo GIA Reinforced Reload with Tri-Staple technology.

With the two major approvals in hand, Covidien is planning to commercialize the new product in both the U.S. and the Japanese markets.

In first-quarter fiscal 2014 (ended Dec 27, 2013) Covidien generated sales worth $1.26 billion from its Surgical Solutions product line which represented roughly 47% of its total revenues. The twin regulatory approvals should considerably boost revenues in the Surgical Solutions product line going forward.

Additionally, the company is banking on the effective execution of its strategy of innovation, customer-focused portfolio management, expansion in emerging markets and operational leverage, with an eye to augment growth in the future.

Currently, Covidien carries a Zacks Rank #2 (Buy).

Investors interested in the medical products industry can also look at other well-placed stocks like NuVasive, Inc. (NUVA - Free Report) , Baxter International Inc. (BAX - Free Report) , and Stryker Corp. (SYK - Free Report) . While NuVasive, carries a Zacks Rank #1 (Strong Buy), both Baxter and Stryker hold the same Zacks Rank as Covidien.

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