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NEW PRODUCTS / PRODUCT NEWS
New Shoulder Restoration
System
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CONMED Linvatec arthroscopy unit
announced July 7, 2009, that it has
launched its Linvatec Shoulder Restoration
System (Linvatec SRS).
The Linvatec Shoulder Restoration
System is a comprehensive system for
rotator cuff repair that supports
a number of surgical techniques and
is designed to facilitate secure reconstruction
and provide optimal tissue tensioning.
The company notes that this system
allows the surgeon to choose from
any of the most advanced rotator cuff
repair techniques, including single-row,
double-row, and transosseous-equivalent
fixation.
The Linvatec SRS is composed of several
components, including:
The PopLok™ Knotless Suture
Anchor. Designed for primary and lateral
row fixation, the PopLok™ is
an all-PEEK (Polyetheretherkeytone)
anchor offered in 3.5-mm and 4.5-mm
sizes. The PopLok™ provides
for tensioning sutures separately
from anchor seating as well as for
securing the sutures regardless of
bone quality. The PopLok™ is
cannulated to channel growth factors
to the repair site.
The CrossFT™ Fully Threaded
Suture Anchor. Composed of PEEK, the
CrossFT™ is offered in 4.5-mm,
5.5-mm, and 6.5-mm sizes with various
suture configurations. Incorporating
both a fully threaded design and a
dual-thread profile, the CrossFT™ provides
a radiolucent option with significant
fixation strength. The CrossFT™ is
also cannulated to channel growth
factors to the repair site.
The Super Revo-FT™ and ThRevo-FT™ Fully
Threaded Suture Anchors. These 5.0-mm
titanium anchors are offered with
2 or 3 sutures, respectively. These
anchors offer an option for surgeons
who prefer to visualize the anchor
after rotator cuff repair while capitalizing
on the proven Revo® design. The
self-drilling Revo design eliminates
a step during the insertion process
to save OR time.
CONMED Linvatec has also developed
a pilot hole instrumentation system
aimed at providing more options for
accessing and repairing shoulder pathology
in the rotator cuff. The company notes
that its patent-pending broaching
punch simultaneously enhances fixation
and reduces stress fractures to bone.
An animated surgical technique video
can be found at http://srs.linvatec.com/.
For
more information, contact
CONMED Linvatec
Customer Service
phone (800) 237-0169
fax (727) 399-5256
e-mail: custserv1@linvatec.com (hours:
7:00 AM - 7:00 PM EST). |
Injectable Osteoinductive
Bone Graft Substitute
| Wright Medical Group, Inc., has announced 510K clearance
of PRO-STIM™ Injectable Osteoinductive Bone Graft Substitute.
PRO-STIM™ graft is a composite grafting material that is injected
through a small needle, hardens, and is replaced by the patient’s
new bone over time.
PRO-STIM™ graft provides surgeons with the osteoconductive
base material derived from PRO-DENSE® graft (a patent-pending
combination of calcium sulfate and calcium phosphate materials),
but adds a high volume of osteoinductive demineralized bone matrix
to the formulation. In Wright’s pivotal preclinical testing,
PRO-STIM™ graft outperformed autograft—long considered
the grafting “gold standard”—at 13 weeks.
The FDA clearance will allow Wright’s PRO-STIM™ Osteoinductive
Graft to be made available immediately to a limited group of trial
centers to validate the preclinical findings in clinical use. Following
successful clinical use, a full roll-out in the United States and
select international markets by the second half of 2010 is planned.
To learn more, contact
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002
phone (800) 238-7117
fax (901) 867-9534
www.wmt.com |
Bone-Targeted Enzyme
Replacement Therapy
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Enobia Pharma announced positive data from a clinical study of ENB-0040, a
bone-targeted enzyme replacement therapy, under investigation for the treatment
of hypophosphatasia (HPP). After 6 months of treatment with ENB-0040, 4 of
5 severely affected patients showed marked improvements in bone mineralization,
correction of skeletal defects, better respiratory function, including weaning
from assisted ventilation, and cognitive and motor development.
HPP is a genetic disease characterized primarily by defective bone mineralization
and is caused by a deficiency in the enzyme tissue–non-specific alkaline
phosphatase (TNSALP). This enzyme plays a key role in regulating skeletal mineralization.
There are currently no therapies approved for HPP. Enobia notes that, as an
enzyme replacement therapy designed to specifically target TNSALP to the bones,
ENB-0040 may help correct the enzyme deficiency and restore bone mineralization.
ENB-0040, an investigational treatment for HPP, is a subcutaneous enzyme replacement
therapy of TNSALP fused to a patented bone-targeting peptide. ENB-0040 is designed
to directly target TNSALP to the bone in order to correct the enzyme deficiency,
which could lead to restoration of normal bone mineralization. ENB-0040, awarded
orphan designation in the United States and Europe in 2008 and FDA Fast Track
status in 2009, is currently in Phase 2 clinical development.
To learn more, contact
Enobia Pharma Inc.
2901, Rachel Street East, Suite 23
Montreal, QC H1W 4A4 Canada
phone (514) 596-2901
fax (514) 596-2749
www.enobia.com |
Ceramic-On-Metal
Implant
| DePuy
Orthopaedics, Inc., announced that
the Orthopaedic and Rehabilitation
Devices Advisory Committee of the
US Food and Drug Administration (FDA)
has unanimously recommended approval
of the Pinnacle® CoMplete™ Acetabular
Hip System, the first ceramic-on-metal
hip bearing to be considered for
approval in the United States.
The panel’s recommendation was
based in part on results from a 2-year
controlled, randomized, blinded, prospective,
multicenter, non-inferiority clinical
study and laboratory testing that compared
the safety and effectiveness of the
Pinnacle CoMplete System with a commonly
used DePuy metal-on-metal implant.
The clinical study showed no significant
difference in adverse events, revision
rates, or survivorship after 2 years,
and patients experienced similar pain
relief, improved function, and range
of motion. Laboratory testing on the
Pinnacle CoMplete System showed >90%
reduction in wear compared with the
metal-on-metal system under normal
gait conditions and >80% reduction
in wear under adverse conditions.
Conditions for approval recommended
by the panel include refinements to
the proposed product labeling and a
post-approval study. The Pinnacle CoMplete
System is currently an investigational
device limited by US law to investigational
use only. A DePuy ceramic-on-metal
bearing has been marketed in 40 countries
outside the United States since 2007.
For more information, contact
DePuy Orthopaedics,
Inc.
700 Orthopaedic Drive
Warsaw, IN 46582
phone (800) 473-3789
fax (574) 371-4865
www.depuy.com |
Apple
iPhone App
The Apple iPhone
App “BoneTestSports09,” developed
by Frank Griffin, MD, consists
of 50 multiple-choice questions
in orthopedic sports medicine.
Each question is designed to cover
a specific topic, and each answer
contains additional information
about that topic. The answers are
displayed on the screen with an
interactive button. Users simply
pick whichever answer they think
is best by tapping on their choice
with a finger. The program will
then alert users whether or not
the answer is correct and
give some additional pertinent information.
This program aims to give the orthopedic
surgeon an easy tool for reviewing
sports medicine in brief stints,
such as between surgical cases or
even in clinic. It is meant to cover
material that typically has to be
memorized and to present the material
in a manner that is more likely to
be remembered through interaction
with an iPhone or iPod Touch.
The “BoneTestSports09” App
sells for $7.99 on the “App
Store” through iTunes, available
on the Apple Web site (www.apple.com).
Once the user has downloaded iTunes,
an icon should be available on the
desktop. From an iPhone or iPod Touch,
it is also available by simply clicking
on the App Store icon on the home
screen and entering the name of the
App in the search box. A similar
App for pediatric orthopedics, entitled “BoneTestPeds09,”sells
for $4.99 on the same site. If there
is adequate interest, future releases
in other orthopedic subspecialties
are planned.
For more information, go to: www.apple.com or www.appsfordoctors.com. |
Screw
System
US Spine® announced
the commercial launch of the Preference
2 Complex Spine System™.
The new system is a hook, rod,
and pedicle screw system with several
implant options allowing multiple
correction techniques and comprehensive
instrumentation designed specifically
to treat complex spinal pathologies.
The company notes that the system
provides spine surgeons with a
specialized solution to correct
complex spinal pathologies such
as scoliosis, kyphosis, trauma,
and tumors.
Advanced correction instrumentation,
cobalt chrome rods, lateral-offset connectors, hooks, rod-to-rod
connectors, and a low-profile cross-connector
are among the many components of
the system. All anchoring implants
within the system feature the Helical
Flange® Closure mechanism, which
eliminates head splay and drastically
reduces cross-threading.
For more information, contact
US Spine
3600 FAU Boulevard, Suite 101
Boca Raton, FL 33431
phone (561) 36-SPINE
fax (561) 367-9627
www.us-spine.com |
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