Statement regarding RENASYS™ NPWT in the United States
LONDON, June 23, 2014 /PRNewswire/ -- Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.
This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.
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 its concerns in order to resume distribution of RENASYS products in the United States as soon as possible and regrets any disruption caused to customers.
Sales of RENASYS products in the United States accounted for less than 5% of global Advanced Wound Management revenue in 2013.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
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