Merit Medical Announces 510 (K) Clearance for the Merit Laureate (TM) Hydrophilic Guide Wire


Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and gastroenterology, today announced that it has received 510(k) clearance from the FDA for the Merit Laureate(TM) hydrophilic guide wire.

Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer said, 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

"This product will be sold in both our cardiology and radiology sales points," Lampropoulos added. "Procedures that include drainage catheter access, dialysis catheter placement as well as difficult vascular access procedures commonly use hydrophilic guide wires."

The Merit Laureate(TM) 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. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy.