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SBi Launches RHead(TM)
Lateral Radial Head Implant And RHead(TM) Plating Systems To Expand Its
Elbow Management System
29
Sept 2007
As
edited by Joint-Pain-Forum.com
Small Bone Innovations, Inc. (SBi), a single-source provider of products,
technology and education for the small bone and joint orthopedic market sector,
announced the launch of the rHead(TM) Lateral Radial Head Implant System. To
further augment its Elbow Management System, the company also launched the
rHead(TM) Plating System for internal fixation of proximal radius
fractures.
The rHead Lateral Implant is a side-loading radial head
prosthesis that allows for a minimally invasive approach and exposure in radial
head replacement surgery. The head and stem of the implant connect by the means
of a dove-tail locking mechanism that does not require a set screw - saving time
in the operating room.
The rHead implant and new plating systems have
received 510(k) clearance by the FDA. The rHead Lateral is indicated for
treatment of arthritic and traumatic conditions of the radial
head.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The
addition of the rHead Lateral implant and the complementary new plating system
responds to surgeon demand for a full range of treatment options for every
disease stage or severity of trauma in the elbow."
The stem of the rHead
Lateral implant is plasma coated with titanium for immediate stability in the
canal and optimum osteo-integrating properties. As with SBi's existing rHead
implants, the stem has a 12-degree curve to match the anatomy of the radius.
This stem is available with a 2 mm standard collar or a 6 mm extended
collar.
"The modularity of treatment options now available from SBi is
making the often complicated alignment challenges in elbow repair or
reconstruction more manageable and predictable in outcome," said Amit Gupta,
M.D, who completed the first procedure using the Lateral rHead at the Louisville
Arm and Hand Center.
"A unique feature of the system is the coupling
mechanism between the radial head and stem that enables the implant to be
implanted sideways to reduce ligament disruption," Dr. Gupta
added.
According to SBi, surgeons have been instrumental in creating the
Elbow Management System. The first rHead(TM) device was released in 1999 by
Avanta (later acquired by SBi) and two years later a bi-polar version, the rHead
Recon was introduced.
This was followed last year with the introduction
of the SBi UNI-Elbow Radio Capitellum System(TM) as the first commercially
available uni- compartmental elbow arthroplasty system. The new rHead Lateral
implant heads are approved for use with the UNI-Elbow System for patients
requiring a uni- compartmental solution.
Surgeons using SBi's Elbow
Management System are also benefiting from the company's Precise Guidance
Technology (PGT(TM)) instrument system that assists anatomical placement of the
rHead implants. The trialing system helps to size the implant to render it as
minimally invasive as is practicable.
The new rHead Lateral implant comes
with an assembly tool for quick engagement or disengagement of the head and
stem. The accompanying impactor tool is configured to assure precise positioning
of the implant by referencing the surrounding anatomy.
----------------------------
Article
adapted by
www.Joint-Pain-Forum.com from original press release.
----------------------------
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc.
(SBi) was founded in 2004 by Viscogliosi Brothers, LLC, (VB), the New York-based
merchant banking firm that specializes in the musculoskeletal/orthopedic sector.
VB created SBi as the first company to focus purely on small bone & joint
science. By integrating established companies and professionals in the field,
SBi can offer a broad, clinically proven portfolio of products and technologies
to treat trauma and diseases in small bones & joints. Today, SBi has more
than 130 employees at facilities in New York, NY, Morrisville, PA, and
Bourg-en-Bresse, France.
SBi was a 2006 recipient of Red Herring
magazine's annual "Red Herring 100 North America" award, recognizing SBi as one
of the nation's leading technology companies and the only orthopedic device
company selected among an initial entry of more than one thousand
firms.
Additionally, SBi's Artelon(R) CMC-I Spacer, developed for
patients with osteoarthritis at the base of the thumb, was featured on the cover
and highlighted within Medical Design Technology magazine's "Year of Innovation"
issue as one of the most fascinating technologies influencing the medical device
industry.
Medical Device & Diagnostic Industry magazine named SBi to
its list of "50 Companies to Watch" in 2006, noting, "Small Bone Innovations is
going against the grain in its determination to become a market leader in the
small bone & joint device sector."
For more information on SBi,
please visit: http://www.totalsmallbone.com
About Viscogliosi
Bros., LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi
and Anthony G. Viscogliosi in New York City in 1999, Viscogliosi Bros., LLC (VB)
was the first venture capital/private equity and merchant banking firm dedicated
to the musculoskeletal/orthopedics sector of the health care
industry.
Today, VB is a leading independent firm with a mission to
create, build and finance companies founded on innovations developed by surgeons
and uniquely focused on "life changing" musculoskeletal/orthopedic technologies.
VB has worldwide surgeon, industry and trade relationships and significant
financial expertise in the musculoskeletal/ orthopedic sector.
As
principals of VB, the Viscogliosi brothers have a combined total of nearly half
a century of experience analyzing and investing in the
musculoskeletal-orthopedics sector, directing literally billions of dollars
through the orthopedics industry.
The Viscogliosi brothers have pioneered
innovative financial, strategic and management initiatives for nearly 150
companies in the sector, from start- up, seed and development stage all the way
to exit, while helping people lead better lives through the orthopedic and
spinal products marketed and sold by the companies they have assisted in
developing and financing. For more information about VB, please visit: http://www.vbllc.com
Forward-looking
statements:
This press release contains forward-looking statements as
defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers
are cautioned not to place undue reliance on these forward-looking statements.
Actual results may differ materially from those indicated by these
forward-looking statements as a result of risks and uncertainties impacting
SBi's business including increased competition; the ability of SBi to expand its
operations and to attract and retain qualified professionals; technological
obsolescence; general economic conditions; and other risks.
Small Bone
Innovations, Inc.
http://www.totalsmallbone.com
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