Merit Medical Systems Inc. (MMSI) announced that it has received 510(k) clearance from the FDA for the Merit Laureate hydrophilic guide wire. The Merit Laureate guide wire is fabricated from a unique core nitinol wire, covered with a urethane jacket and coated with a proprietary process that produces a slippery surface. The project, which was code-named "The Irish Project" is scheduled for worldwide release in January 2010.
"This 510(k) clearance from the FDA is the culmination of three years of challenging research that we believe will position Merit as a major player in a $150-200 million hydrophilic guide wire market. Over the next several years, we believe this product will be able to produce approximately $30 million in sales with gross margins exceeding current company averages," said Fred Lampropoulos, Merit's Chairman and Chief Executive Officer.
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