Tuesday, medical devices maker Merit Medical Systems Inc. (MMSI) announced that it has received 510(k) clearance from the FDA for the Merit Laureate hydrophilic guide wire. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification.
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.
Fred Lampropoulos, Merit's Chairman and Chief Executive Officer said,"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. This product will be sold in both our cardiology and radiology sales points. Procedures that include drainage catheter access, dialysis catheter placement as well as difficult vascular access procedures commonly use hydrophilic guide wires."
MMSI is currently being traded at $17.52 up $0.34 or 1.98% on a volume of 34,377 thousand shares on the Nasdaq.
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