FDA Nod for Merit's Guide Wire

Merit Medical Systems, Inc. (MMSI - Snapshot Report), a medical device company, recently obtained the clearance of the U.S. Food and Drug Administration (FDA) 510(k) to commercialize its Merit Laureate hydrophilic guide wire.

Following the FDA approval, it will be possible for Merit Medical to again market its Laureate hydrophilic guide wire in the U.S., which was discontinued earlier this year when the company received a warning letter from the FDA in February 2012. The FDA desired additional information about the modifications in the manufacturing process of the Laureate hydrophilic guide wire.

While the sale of Laureate hydrophilic guide wire was discontinued in the domestic market, the product continued to garner revenues in the international market, especially in China. Management believes that the offering provides a notable commercial opportunity in the domestic market as well.

Earlier, Merit Medical obtained the FDA 510(k) clearance for its Resolve Biliary Drainage Catheter and Concierge Guiding Catheter. Expectations from these newer offerings to bolster its top-line are high. Also worth mentioning in this context is management’s plans to extend its portfolio of hydrophilic wires by introducing additional varieties of the Laureate hydrophilic guide wire.

South Jordan, Utah-based Merit Medical provides disposable medical devices for cardiology, radiology, endoscopy and other interventional and diagnostic procedures. Founded in 1987, the company owns manufacturing facilities across U.S., Europe and China.

According to Merit Medical, its ability to develop and manufacture innovative products with proprietary technology will allow it to gain market share. Additionally, the company has significant international presence with China emerging as a major growth driver. It also plans to gain foothold in the BRIC nations and Balkan states.

Merit Medical strategizes to evolve as a provider of primary use products, apart from its accessory products. However, the company faces intense competition from large, diversified international players like Boston Scientific Corporation (BSX - Analyst Report), C.R. Bard (BCR - Analyst Report) as well as medium-size medical devices companies such as AngioDynamics (ANGO - Analyst Report) and ICU Medical (ICUI - Snapshot Report).

Merit Medical currently has a Zacks #2 Rank, which translates into a short-term Buy rating.