Smith & Nephew has temporarily ceased commercial distribution of the Renasys negative pressure wound therapy (NPWT) product line in the United States.
This action follows instruction from the U.S. Food and Drug Administration (FDA) to obtain new regulatory clearances through the premarket notification 510(k) process "in respect of certain design enhancements made to Renasys systems," according to the company. The applications for clearance have been filed and are awaiting action, officials said.
This action only affects Renasys products in the United States. Other NPWT products, including PICO, Smith & Nephew’s portable, canister-free system, are not affected.
"Smith & Nephew is working cooperatively with the FDA to address the agency's concerns in order to resume distribution of the products in the United States as soon as possible and regrets any disruption caused to customers," company officials said in a statement.
Sales of Renasys products in the United States accounted for less than 5 percent of the firm's global Advanced Wound Management revenue in 2013.