FDA clears Teleflex’s latest midline catheter for U.S. market

The FDA granted Teleflex ($TFX) 510(k) clearance to begin marketing its Arrow Midline with Chlorag+ard technology for use in the U.S. market.

The device is an antithrombogenic and antimicrobial peripheral venous catheter that minimizes common midline catheter complications such as catheter intraluminal occlusion, thrombus accumulation and microbial colonization on the catheter surface for at least 30 days, the company said.

Additionally, the device allows caregivers to more easily protect the catheter from potential costly complications.

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Teleflex's Arrow unit makes a variety of the catheters under the brand names of UltraFlex, NarrowFlex and RediGuard.

“Clinicians are faced with a multitude of vascular access challenges,” Jay White, president and GM of Teleflex’s Vascular Access Division, said in a statement. “Development of new technology to ensure the patient receives the safest, most effective IV therapy possible should drive all medical device manufacturers.”

Earlier this year, the Wayne, PA-based company issued a global Class I corrective recall of more than 47,000 Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits after it reported the separation of the devices' sheath body from the sheath hub had resulted in six serious injuries and one death.

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