Merit Medical Systems has gained US marketing rights for its new Laureate hydrophilic guide wire following the approval from the US Food and Drug Administration (FDA).
The new disposable guide wire is designed for use during performing endoscopy, cardiology and radiology procedures.
The FDA sent a warning letter in February 2012 to the company seeking additional information about the modifications made in the manufacturing process.
The company has complied the relevant information and submitted a new 510(k) application to the FDA for review.
During the review period, the company discontinued sales of the Merit Laureate in the US, but continued to market the product which is manufactured in Galway, Ireland, in international markets.
Merit Medical chairman and chief executive officer Fred Lampropoulos said the company is pleased to conclude the process and provide the new product immediately to its US customers.
"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," Lampropoulos added.