Smith & Nephew (FTSE:SN, NYSE:SNN) announced today that it put a temporary halt on U.S. sales of its Renasys negative wound therapy products in order to seek new premarket clearance, as requested by the FDA.
U.S. medtech regulators asked Smith & Nephew to resubmit the product in light of design changes that the FDA believes represent a substantial change from earlier iterations of the technology.
The company said that it’s "working cooperatively with the FDA to address its concerns in order to resume distribution of Renasys products in the U.S. as soon as possible and regrets any disruption caused to customers."
U.S. sales of the Renasys product represent less than 5% of Smith & Nephew’s global advanced wound management revenue, the company said. The temporary suspension in sales doesn’t apply to any other of the company’s wound care products.
The Renasys line includes the GO mobile wound therapy system and the EZ updated system, both released in 2009. The products work with the Renasys-F foam and Renasys-G gauze wound interfaces to help clinicians to treat a variety of wounds.
The Renasys products were also the subject of a patent battle with rival Kinetic Concepts Inc., which claimed that Smith & Nephew’s Renasys F negative-pressure wound therapy device violated a pair of patents owned by Wake Forest University and licensed to KCI.