FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew's Birmingham Hip Resurfacing Technology
09 September 2005 - 9:30AM
PR Newswire (US)
MEMPHIS, Tenn., Sept. 8 /PRNewswire-FirstCall/ -- Smith &
Nephew Orthopaedics (NYSE: SNN; LE: SN) announced today that the
U.S. Food and Drug Administration's Orthopedic and Rehabilitation
Devices Advisory Panel recommended conditional approval of the
Company's pre-market approval application (PMA) for its Birmingham
Hip Resurfacing (BHR) technology. The Company submitted a PMA for
its BHR technology on July 19, 2004. The conditions recommended by
the panel relate to the post marketing trial follow-ups. Smith
& Nephew's BHR technology has been used in over 33,000 patients
since 1997, and this procedure has demonstrated significant
positive clinical endpoints in the United Kingdom, Germany and
Australia. The hip resurfacing procedure involves the replacement
of the articular surfaces of the femur and acetabulum, leaving the
femoral head substantially preserved. The device is intended to
relieve hip pain and improve hip function in patients who have
adequate bone stock and who wish to lead active lives. "With our
unique OXINIUM(TM) technology, the recent introduction of our
ceramic-on-ceramic hip and this further step towards approval in
the US of our BHR technology, we are confident that Smith &
Nephew will possess the broadest and most comprehensive portfolio
of orthopaedic bearing surfaces," said David Illingworth. Smith
& Nephew acquired Midland Medical Technologies and its
principal product, Birmingham Hip Resurfacing in 2004. About us
Smith & Nephew is a global medical technology business,
specializing in Orthopaedics, Endoscopy and Advanced Wound
Management products. Smith & Nephew is a global leader in
arthroscopy and advanced wound management and is one of the fastest
growing global orthopaedics companies. Smith & Nephew is
dedicated to helping improve people's lives. The company prides
itself on the strength of its relationships with its surgeons and
professional healthcare customers, with whom its name is synonymous
with high standards of performance, innovation and trust. The
company has over 8,500 employees and operates in 33 countries
around the world generating annual sales of $2.3 billion.
Forward-Looking Statements This press release contains certain
"forward-looking statements" within the meaning of the US Private
Securities Litigation Reform Act of 1995. In particular, statements
regarding expected revenue growth and operating margins discussed
under "Outlook" are forward-looking statements as are discussions
of our product pipeline. These statements, as well as the phrases
"aim," "plan," "intend," "anticipate," "well-placed," "believe,"
"estimate," "expect," "target" "consider" and similar expressions,
are generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties and other important factors (including, but not
limited to, the outcome of litigation, claims and regulatory
approvals) that could cause the actual results, performance or
achievements of Smith & Nephew, or industry results, to differ
materially from any future results, performance or achievements
expressed or implied by such forward- looking statements. 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 20F, for a discussion of certain
of these factors. All forward-looking statements in this press
release are based on information available to Smith & Nephew as
of the date hereof. All written or oral forward-looking statements
attributable to Smith & Nephew or any person acting on behalf
of Smith & Nephew are expressly qualified in their entirety by
the foregoing. Smith & Nephew does not undertake any obligation
to update or revise any forward-looking statement contained herein
to reflect any change in Smith & Nephew's expectation with
regard thereto or any change in events, conditions or circumstances
on which any such statement is based. DATASOURCE: Smith &
Nephew plc CONTACT: Liz Hewitt, Group Director Corporate Affairs of
Smith & Nephew plc, + 44-207-960-2256
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