Merit Medical Receives 510(k) Clearance to Market the Merit Laureate(R) Hydrophilic Guidewire
SOUTH JORDAN, Utah, Sept. 24, 2012 (GLOBE NEWSWIRE) -- Merit Medical
Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of
proprietary disposable devices used primarily in cardiology, radiology
and endoscopy, today announced that it has received 510(k) clearance
from the Food and Drug Administration to market the Merit Laureate(R)
hydrophilic guide wire.
In February 2012, Merit Medical received a warning letter from the FDA
regarding modifications in the manufacturing process for which the FDA
required additional information. Merit complied by filing a new 510(k)
submission.
Merit discontinued sales of the Merit Laureate(R) during the review
period in the United States, but continued to market the product, which
is manufactured in Galway, Ireland, in international markets.
"We are pleased to conclude this process and provide this product
immediately to our U.S. customers," said Fred P. Lampropoulos, Merit
Medical's Chairman and Chief Executive Officer. "We believe this
segment of the guide wire business offers substantial opportunity and
intend to introduce additional hydrophilic wires upon regulatory
clearance in the near future."
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the
development, manufacture and distribution of proprietary disposable
medical devices used in interventional and diagnostic procedures,
particularly in cardiology, radiology and endoscopy. Merit serves
client hospitals worldwide with a domestic and international sales
force totaling approximately 165 individuals. Merit employs
approximately 2,700 people worldwide with facilities in Salt Lake City
and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht
and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing,
China; Copenhagen, Denmark; and Rockland, Massachusetts.
