Merit Medical Systems, Inc.
), 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
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
Boston Scientific Corporation
) as well as medium-size medical devices companies such as
Merit Medical currently has a Zacks #2 Rank, which translates
into a short-term Buy rating.
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