Small Bone Innovations, Inc. (SBi) today announced that on Sept. 30,
2014 the sale of the assets of its international business, including the
assets of its French, German and Asia Pacific operations, to Stryker
Corporation SYK was completed.
In a news release issued Aug. 1, 2014, Stryker reported it closed on the
acquisition of substantially all of SBi's North American assets.
"With its global sales, marketing and distribution resources, Stryker is
well positioned to take SBI's full range of arthroplasty products to a
much greater patient population, and, in particular, the STAR total
ankle replacement system. The STAR Ankle is the number one total ankle
replacement system in the world and is the only total ankle replacement
system approved for uncemented use through the U.S. Food and Drug
Administration's (FDA) rigorous Premarket Approval (PMA) process. The
Investigational Device Exemption (IDE) study, which was a prerequisite
to obtaining PMA, demonstrated STAR to be 'superior in efficacy and
comparable in safety to fusion.' (1) The IDE and other subsequent
studies show that the STAR ankle has better pain relief, greater
clinical success, less blood loss and a shorter operating time than
fusion. The low profile and bone conserving design favored by patients
combined with its simple, easy to use instrumentation system favored by
surgeons has led to its favorable reception in the marketplace," said
Anthony G. Viscogliosi, chairman and CEO of SBi.
"We believe the ankle market is at an inflection point of conversion
from fusion to arthroplasty and STAR Ankle will be driving the market as
a product innovator and the most clinically researched total ankle
system in the world. Furthermore, the STAR ankle replacements last long
term and provide relief for patients as demonstrated by the long-term
study conducted by foot and ankle surgeons Jeffrey A. Mann M.D., Roger
A. Mann M.D. and Eric Horton M.D. that reported 91 percent survivorship
at an average follow-up of 9.1 years with 92 percent patient
satisfaction(2) .
(1) Charles L. Saltzman et al: 'Prospective Controlled Trial of STAR,
Total Ankle Replacement Versus Ankle Fusion: Initial Results' Foot &
Ankle International/Vol.30, No. 7/July 2009
(2) Foot & Ankle International (May 2011 edition, Volume 32 #5 (c)
American Orthopaedic Foot & Ankle Society)
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