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FDA Clears Guide Wire from Merit

The agency's OK comes following a warning letter earlier in the year.

By: Niki Arrowsmith

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Merit Medical Systems Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Merit Laureate hydrophilic guide wire. The company manufactures proprietary disposable devices used primarily in cardiology, radiology, and endoscopy.

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 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 CEO. “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.”

The Merit Laureate hydrophilic guide wire is designed to facilitate the placement of devices during diagnostic and interventional procedures. It features torque control, turn-for-turn responsiveness, and is able to cross lesions with ease, which improves navigation of convoluted vessels, claims the company. The wire’s hydrophilic coating reportedly demonstrates lubricity and consistent surface coating adhesion. The Laureate is designed to reduce wire whipping, minimize friction, and to promote rapid catheter exchanges.

Merit Medical Systems is based in South Jordan, Utah.



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