Merit Medical Wins FDA Approval for Multiple Devices - Analyst Blog

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Developer of medical devices, Merit Medical Systems, Inc. (MMSI), recently announced that the U.S. Food and Drug Administration (FDA) has approved three of its products under section 510(k).

The three products that received a go-ahead from the FDA are the ReSolve Biliary Locking Drainage Catheter, the ONE Snare Endovascular Microsnare System and the AEROmini Tracheobronchial Stent System.

All the three products, according to management, will be launched in the U.S. at the beginning of 2015. This should enhance Merit Medical's existing product portfolio and help it gain an edge in the competitive medical devices market.

The product launches are expected to boost top-line growth for Merit Medical Systems. In the recent concluded quarter, Merit Medical Systems' revenues of $129 million were in line with the Zacks Consensus Estimate. On a year-over-year basis, revenues increased 12%.

Notably, in the third quarter of 2014, catheter sales grew 20% on a year-over-year basis. The new Biliary Locking Drainage Catheter is expected to further boost sales of catheters and subsequently aid top-line growth.

Things have been in a good shape for Merit Medical Systems for sometime now. Merit Medical Systems recently settled a dispute with Bard Access Systems regarding the distribution of the SecureLoc Safety Introducer Needle.

Under the terms of a settlement agreement, Merit Medical was granted a non-exclusive, worldwide license to manufacture and distribute the SecureLoc Safety Introducer Needle.

Merit Medical Systems, few months back, received a clearance for PreludeEASE hydrophilic radial sheath. The radial approach is slowly receiving acceptance in the country. The company also launched the ThinkRadial website, which is expected to enhance the company's radial initiatives.

If we focus on the medical devices market, it has quite a number of peers who are fighting for a healthy market share. It remains to be seen whether the new range of products and services at Merit Medical can counter similar offerings from the likes of AngioDynamics Inc. (ANGO), Teleflex Inc. (TFX) and Boston Scientific Corp. (BSX).

Currently, Merit Medical Systems has a Zacks Rank #2 (Buy).


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