Statement regarding RENASYS™ NPWT in the United States
LONDON, June 23, 2014
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).
For more information about Smith & Nephew, please visit our corporate website
www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit
SmithNephewplc on Facebook.com
This document may contain forward-looking statements that may or may not prove
accurate. For example, statements regarding expected revenue growth and
trading margins, market trends and our product pipeline are forward-looking
statements. Phrases such as "aim", "plan", "intend", "anticipate",
"well-placed", "believe", "estimate", "expect", "target", "consider" and
similar expressions are generally intended to identify forward-looking
statements. Forward-looking statements involve known and unknown risks,
uncertainties and other important factors that could cause actual results to
differ materially from what is expressed or implied by the statements. For
Smith & Nephew, these factors include: economic and financial conditions in
the markets we serve, especially those affecting health care providers, payers
and customers; price levels for established and innovative medical devices;
developments in medical technology; regulatory approvals, reimbursement
decisions or other government actions; product defects or recalls; litigation
relating to patent or other claims; legal compliance risks and related
investigative, remedial or enforcement actions; strategic actions, including
acquisitions and dispositions, our success in performing due diligence,
valuing and integrating acquired businesses; disruption that may result from
transactions or other changes we make in our business plans or organisation to
adapt to market developments; and numerous other matters that affect us or our
markets, including those of a political, economic, business, competitive or
reputational nature. Please refer to the documents that Smith & Nephew has
filed with the U.S. Securities and Exchange Commission under the U.S.
Securities Exchange Act of 1934, as amended, including Smith & Nephew's most
recent annual report on Form 20-F, for a discussion of certain of these
factors. Any forward-looking statement is based on information available to
Smith & Nephew as of the date of the statement. All written or oral
forward-looking statements attributable to Smith & Nephew are qualified by
this caution. Smith & Nephew does not undertake any obligation to update or
revise any forward-looking statement to reflect any change in circumstances or
in Smith & Nephew's expectations.
™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark
SOURCE Smith & Nephew
Contact: Investors, Phil Cowdy, +44 (0) 20 7401 7646, Smith & Nephew, Media,
Charles Reynolds, 44 (0) 20 7401 7646, Smith & Nephew, Trade Media, Suzanne
Miller, +1 646 405 5992, Magellan Communications
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