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NEW PRODUCTS / PRODUCT NEWS
Shortwave Diathermy
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DJO Incorporated, a global provider
of medical devices that deliver solutions
for musculoskeletal health, vascular
health, and pain management, announced
that its Chattanooga business has
received 510(k) clearance from the
US FDA to market and sell the Intelect® SWD
Shortwave Diathermy device in the
United States. Plans are under way
to bring the unit to market in spring
2009.
Chattanooga’s new Intelect
SWD innovations include a touch screen
interface and onboard software that
allows therapists to customize their
patient’s therapy. DJO notes
that the Shortwave Diathermy unit
is the only domestic shortwave product
to operate via a touch screen interface.
The unit is very simple to use. Therapists
can begin treatment in as few as 2
touches to the home screen.
Shortwave
diathermy is a clinical treatment
modality that provides a superior
form of deep-tissue heating. Indications
for use include: pain relief, reduction
of muscle spasm, decreasing joint
stiffness, contractures, increased
blood flow, chronic inflammatory conditions,
bursitis, tenosynovitis, synovitis,
and chronic inflammatory pelvic disease.
For
more information, contact
DJO, LLC.
1430 Decision Street
Vista, CA 92081
phone (760) 727-1280
fax (800)
936-6569
www.djoglobal.com
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Injectable Paste and Moldable
Putty
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ETEX Corporation announced FDA 510k clearance of 1-cm3 and 2.5-cm3 sizes
of Beta-bsm™ Injectable
Paste and Gamma-bsm™ Moldable Putty to complement the existing 5-cm3and
10-cm3 sizes. Both products are bone-substitute mate-rials based on
ETEX’s
proprietary nanocrystalline calcium phosphate technology.
Beta-bsm™ and Gamma-bsm™ set hard to provide an optimal osteoconductive
scaffold that mimics the nanocrystalline structure of human bone. Smaller sizes
were developed in direct response to the needs of the small-bone market. Both
hand and foot/ankle surgeons requested user-friendly moldable and injectable
materials that set fast, are drillable, provide high compressive strength, and
remodel into bone over time.
Beta-bsm™ Injectable Paste and Gamma-bsm™ Moldable
Putty are intended for use in filling bone voids or defects of the skeletal system
(including extremities, pelvis, and spine) that are not intrinsic to the stability
of the bone structure.
For more information, contact
ETEX
38 Sidney Street
Cambridge, MA 02139
phone (617) 577-7270
fax (617) 577-7170
www.etexcorp.com |
Injectable Bone
Graft Replacement
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DePuy Spine, Inc., announced the launch of HEALOS® Fx Injectable
Bone Graft
Replacement (HEALOS Fx), the company’s first bone graft solution designed
specifically for minimally invasive spine surgery. HEALOS Fx is a moldable,
injectable version of HEALOS® Bone Graft Replacement, which
is the company’s
osteoconductive and osteogenic (when combined with bone marrow aspirate) bone
graft substitute
that has been shown to achieve fusion rates equivalent to autograft in peer-reviewed
human clinical studies.1,2
HEALOS Fx is a ready-to-use fibrous material that
can be molded for open applications or injected via cannulas of differing
lengths to reach difficult implantation sites in minimally invasive or small
void surgical
environments. The original form of HEALOS, which exists as pre-formed strips
of varying sizes, has been available for more than 7 years in the United
States and has been used in more than 65,000 procedures nationwide.
DePuy Spine notes that the new HEALOS Fx is a bone graft option for precise placement
into difficult-to-reach surgical sites, particularly around pedicle screws
and the interbody space. In addition, since the chemical composition of HEALOS
and HEALOS Fx is identical, the compelling safety and performance records of
the graft material have been well established.
HEALOS Fx, which has a cohesive
consistency when saturated with the patient’s bone marrow, provides both
a continuous scaffold for bone formation and the osteoprogenitor cells needed
to initiate new bone growth. The material is resorbed and remodeled into new
bone as part of the healing process.
HEALOS Fx was designed using proprietary
DePuy Spine nanotechnology that promotes osteoprogenitor cell attachment
and maturation. HEALOS Fx comes with a self-contained mixing and delivery
device that allows for a smooth, simple mixing motion to create a uniform
graft material in less than 1 minute.
To learn more, contact
DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767
phone (800) 227-6633
fax (800) 446-0234
www.depuyspine.com
References
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Multiple
Potential Spinal Applications
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K2M, Inc., a spinal device company
developing innovative solutions
for the treatment of complex spinal
pathologies, has announced the
debut of a breakthrough injectable
polymer technology. Preliminary
testing indicates the polymer may
have many different applications
for treating a variety of spinal
disorders.
K2M obtained the worldwide exclusive
rights for all spinal applications
of this material through an agreement
with Promethean Surgical Devices,
Inc. (PSD), in November 2008. The
injectable polymer will serve as
a platform for the development of
new implantable technologies. The
company notes that the material
has demonstrated unique properties
that could lead to the development
of a new treatment modality and earlier
intervention to address multiple
pathologies, such as spinal nucleus
replacement, or micro-access surgical
approaches for annular decompression
and repair.
For more information, contact
K2M, Inc.
751 Miller Drive SE, Suite F-1
Leesburg, VA 20175
phone (866)526-4171
fax (703)777-4338
www.k2m.com |
Pain
Score Decrease
| Ferring Pharmaceuticals
recently presented the results of
a 6-month safety and efficacy study
demon-strating that Euflexxa® (1%
sodium hyaluronate) was effective
at decreasing the pain of knee osteo-arthritis
(OA) at 26 weeks.
Euflexxa (1% sodium hyaluronate)
is the first non-avian-derived* hyaluronic
acid (HA) approved in the United
States for treatment of knee pain
due to osteoarthritis (OA). Euflexxa
is indicated for patients who have
failed to get adequate pain relief
either from simple pain medications,
such as acetaminophen, or from exercise
and/or physical therapy. The process
used to manufacture Euflexxa results
in highly purified HA with properties
similar to the HA in healthy human
synovial fluid.1-3
The study showed that Euflexxa
is superior to saline in decreasing
pain at 26 weeks in patients with
OA of the knee.4 Euflexxa
is a 3-injection treatment regimen
indicated for patients
who have failed to respond adequately
to conservative non-pharmacologic
therapy and simple analgesics. The
goal of HA therapy is to reduce pain
and improve physical function by
replenishing the HA in human synovial
fluid.
The multicenter, 26-week, randomized,
double-blind trial compared Euflexxa
and intra-articular buffered saline
(IA-SA) for level of pain following
a 50-Foot Walk Test, measured by
100-mm visual analog scale (VAS).
The 586 patients with chronic idiopathic
knee OA were randomized to treatment
with either product in a 1:1 ratio.
Each patient received 1 weekly injection
for 3 weeks with 9 follow-up visits
over 26 weeks after the first injection.
The Euflexxa group showed an advantage
over saline in pain reduction, with
a larger mean decrease from baseline
in pain scores: -25.7 (28.9) mm versus
-18.5 (32.5) mm respectively, with
a least-squares mean of -6.6 mm (P=0.002).
At 26 weeks, 145 (58%) of Euflexxa
subjects reported a ≥20-mm
improvement in pain based on the
VAS scoring, compared with 120 (46%)
in the other group (P=0.006).
The percentage of Osteoarthritis
Research
Society International (OARSI) responders
for the Euflexxa group was also significantly
greater than that in the other group
(67% versus 59% (P=0.047).
A subject is considered a responder
if there
is a high improvement in pain or
function or improvement in at least
2 of the following 3 categories:
pain ≥20% and absolute change ≥10
mm, function ≥20% and absolute
change ≥10 mm, and/or patient
global assessment ≥20% and
absolute change.
To learn more, contact
Ferring Pharmaceuticals,
Inc.
4 Gatehall Drive, 3rd Floor
Parsippany, NJ 07054
phone (888)FERRING
fax (973)796-1616
www.ferring.com
*Derived through bacterial fermentation.
References
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