|
NEW PRODUCTS / PRODUCT NEWS
Meniscal Tear Repair
|
Cayenne Medical, Inc., has announced
the commercial launch of its CrossFix™ System
for the repair of meniscal tears.
The CrossFix™ system offers
surgeons the benefits of both open
suturing and arthroscopic meniscal
repair. Cayenne Medical notes that
the technology replicates results
from “gold standard” open
suturing techniques but through a
faster and less invasive all-inside
method. Unlike traditional all-inside
meniscal repair devices, the CrossFix™ system
leaves no plastic implants behind.
The CrossFix™ system is a suture-only
device that creates a 3-mm mattress
stitch for an all-inside meniscal
repair. The dual-needle design instantly
deploys a horizontal or vertical mattress
with a pre-tied sliding knot through
a single insertion into the meniscus.
The device includes an incorporated
cannula and depth limiter that controls
needle penetration, reducing the risk
of neurovascular injury. The repair
is biomechanically strong with pull-out
forces equal to open suture techniques.*
The company notes that the CrossFix™ system
is fast and easy to use, offering
surgeons reliable and reproducible
patient outcomes.
In addition to the statistically significant
benefit in pain success at 3 months
and function success at 24 months, the
CORTOSS population experienced measurable
benefits over the PMMA cohort in the
following outcomes: A 43.4% reduction
in subsequent, adjacent-level fractures
in CORTOSS patients treated for a primary
fracture at one level, as measured at
the end of the 24-month follow-up period.
There was 83% follow-up at the 24-month
time point. This study, in combination
with various clinical trials previously
completed in the United States and Europe,
brings the total number of patients
studied for CORTOSS in vertebral compression
fractures to 527.
For
more information, contact
Cayenne Medical,
Inc.
16597 N. 92nd St., Suite 101
Scottsdale, AZ 85260
phone (480)502-3661;
fax (480) 502-3670
www.cayennemedical.com
* Data on file. |
Arthrodesis System
|
Integra LifeSciences Holdings Corporation announced it has received 510(k) clearance
from the US Food and Drug Administration (FDA) for the HALLU®-LOCK MTP
Arthrodesis System. The HALLU®-LOCK System features Surfix® Locking
Technology and is an upgrade of the HALLU®-FIX System. Surfix® Locking
Technology allows the surgeon to place the plate at the optimal distance from
the bone and then lock the screws.
The HALLU®-LOCK System is indicated for use in fixation of fractures, osteotomies,
or arthrodesis of the first metatarsophalangeal joint, including cases of hallux
rigidus, severe hallux valgus, and deformity caused from rheumatoid arthritis.
The HALLU®-LOCK MTP Arthrodesis System will be sold by Integra’s Extremity
Reconstruction sales organization, which focuses on lower-extremity fixation,
upper-extremity fixation, tendon protection, peripheral nerve repair/protection,
and wound repair.
For more information, contact
Integra LifeSciences Holdings Corporation
311 Enterprise Drive
Plainsboro, NJ 08536
phone (800) 654-2873
fax (609) 275-5363
www.Integra-LS.com |
Porous Surgical
Mesh
|
Xylos Corporation announced they have received FDA 510(k) clearance for their
Xylos® Porous Surgical Mesh. This product is intended for implantation
to reinforce soft tissue, including, but not limited to: defects of the abdominal
and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction
of the pelvic floor, hernias, suture-line reinforcement, and reconstructive
procedures. Xylos® Porous Surgical Mesh is intended for one-time use.
To learn more, contact
Xylos Corporation
838 Town Center Drive
Langhorne, PA 19047
phone (215) 867-0220
www.xyloscorp.com |
Osteoconductive
Scaffold
|
Integra LifeSciences Holdings Corporation
announced the Integra Mozaik™ Osteoconductive
Scaffold strip is now available
in a smaller configuration, broadening
Integra’s OrthoBiologics
portfolio and providing surgeons
with a wider selection of products
that will satisfy their bone grafting
needs.
Integra Mozaik™ Osteoconductive
Scaffold is designed to fill bone voids
or gaps in the skeletal system of the
extremities, spine and pelvis. Integra
Mozaik™ guides the regeneration
of new bone across critical defect
sites in which it has been implanted.
New bone formation is initiated in
the matrix surface when the graft is
placed in direct apposition to living
host bone. The matrix is resorbed and
remodeled as new bone is formed. Integra
Mozaik™ incorporates the same
Type I collagen used in several of
Integra’s innovative regenerative
products, including DuraGen® Plus
Dural Regeneration Matrix, NeuraGen® Nerve
Guide, and INTEGRA® Dermal Regeneration
Template. Integra Mozaik™ combines
the collagen matrix with a highly pure
form of beta-tricalcium phosphate to
provide both compression resistance
and a mineral source, 2 properties
essential for bone healing.
When used with bone marrow aspirate
from the patient, Integra Mozaik™ Osteoconductive
Scaffold may replace the need to harvest
bone from the patient’s iliac
crest, thus sparing the patient additional
surgery and postoperative pain.
Integra Mozaik™ Osteoconductive
Scaffold is sold in the United States
through the Integra OrthoBiologics
distributor network.
For more information, contact
Integra LifeSciences
Holdings Corporation
311 Enterprise Drive
Plainsboro, NJ 08536
phone (800) 654-2873
fax (609) 275-5363
www.Integra-LS.com |
Newly
Released Software
| LifeModeler, Inc.,
the leading global provider of biomechanical
human body simulation tools and services,
has released LumbarSIM™. This “virtual
prototyping” software directly
addresses the needs of orthopedic
device manufacturers and surgeons
seeking ways to respond to the growing
numbers of patients experiencing
lower back pain.
The product, which automatically creates
a detailed lumbar spine model and separates
it into individual vertebral segments
and disc forces, integrates easily
into the company’s LifeMOD software.
Its eventual applications in the orthopedic
arena are numerous, especially when
attempting to pre-evaluate surgical
options such as spinal fusion, discectomy,
and laminectomy.
The simplicity of adapting to LumbarSIM’s
architecture is a feature that LifeModeler’s
engineers focused on so that it could
easily serve as a design tool for orthopedic
device developers. Much of the software’s
operational characteristics mirror
the workflow that is commonly found
on a personal computer. Many of the
common tasks have been streamlined
and the modeling language is more user-centric,
making all of the workflow customizable
to fit specific needs. The company
notes that this makes LumbarSIM easily
learned, and easily applied. Reports
generated by the software offer increased
sophistication, including the incorporation
of hypertext, plots, live video, and
model animation.
To learn more, contact
LifeModeler,
Inc
2730 Camino Capistrano, Ste 7
San Clemente, CA 92672
phone (949) 366-6829
fax (866) 709-2197
www.lifemodeler.com |
Icing
System
|
Moji has announced the launch of Moji
Knee—a 2-piece compression ice wrap
that is intended to make the critical step
of post-activity icing more practical and
efficient. Moji’s Cold Cell design
is patent-pending and the compression wrap
provides maximum comfort and allows for
complete mobility and range of motion while
icing.
Moji Knee’s innovative Cold Cell
design is a composite of 18 individual
cold cells. The individual cells work collectively,
form-fitting to the specific shape and
dimensions of the knee to accommodate variances
in each individual’s range of motion,
gait, and unique movement patterns. The
cold cell has a multi-piece construction
that begins with Moji’s cell gel
formula. Moji’s cell gel is engineered
to remain pliable and offer optimal cooling
over the duration of the icing process.
The cell gel is encased in a film engineered
for a soft and supple feel. For optimal
comfort, Moji employs a high-tech Dri-lex® fabric
layer that acts as a soft skin, encasing
the Moji Cold Cell. The highly absorbent
Dri-lex fabric eliminates condensation
and leaking while maximizing comfort.
Moji’s compression wrap design utilizes
Polartec® 4-way stretch fabric to provide
a unique combination of compression that
focuses cooling to targeted areas, range
of motion, and mobility. To ensure maximum
comfort, the wrap features 4 neoprene stretch
tab fastening points that allow the user
to customize the fit to his or her preference.
In addition, Moji has developed Moji To
Go, a stainless steel, thermally insulated
portable canister that keeps the Moji cold
cell at its “frozen state” for
up to 6 hours.
Moji plans to introduce a full line of
products, featuring the same 2-piece design
and optimal cooling characteristics as
Moji Knee. Plans include the introduction
of Moji Back in summer 2009, as well as
Moji Shoulder during the fourth quarter
of 2009. Moji has further plans underway
for additional icing products for other
physical areas commonly affected by exercise
and activity.
For more information, contact
Moji
2700 Patriot Blvd, Suite 420
Glenview, IL 60026
phone ((800) 593-2045
www.gomoji.com |
Intervertebral
Body Fusion Devices
|
K2M, Inc., announced it has received
510(k) clearance from the FDA to market
its ALEUTIAN® Spacer Systems as intervertebral
body fusion devices. The ALEUTIAN
family of 5 different systems offers a
full array of anatomically designed PEEK-OPTIMA® interbody
options, including the anterior-lumbar
interbody fusion (ALIF), small-anterior
(cervical), posterior-lumbar interbody
fusion (PLIF), anatomically narrow (AN),
and transforaminal-lumbar interbody fusion
(TLIF).
K2M notes that ALEUTIAN features radiolucent
properties that have the potential to increase
visualization of bone graft, while allowing
for more accurate fusion assessment. In
addition, the elastic modulus, a physical
property of the material, more closely
matches that of cortical bone for load
sharing with the potential to minimize
stress shielding and enhance fusion results. The
bulleted nose allows for easier insertion
and distraction, and the self-retaining
teeth can potentially provide postoperative
stabilization of the implant.
FDA clearance for the ALEUTIAN Spacer Systems to be marketed as intervertebral
body fusion devices provides surgeons with multiple surgical applications in
the cervical and lumbar spine for the treatment of degenerative disc disease
and spondylolisthesis, as well as more complex applications. The anatomically
designed implants and differentiated surgical instruments facilitate and streamline
surgical applications.
To learn more, contact
K2M, Inc
751 Miller Drive SE, Suite F-1
Leesburg, VA 20175
phone (866) 526-4171
www.k2m.com |
|
