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NEWLY AVAILABLE, NEWLY APPROVED
Tunneling Wound Dressing
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Ferris Mfg. Corp. has introduced PolyMem
WIC® Silver® Rope, a member
of the PolyMem QuadraFoam family of
dressings. Specially designed for
use on cavity, undermining and tunneling
wounds, PolyMem WIC Silver Rope contains
a unique small-particle silver formulation
to help protect the wound bed from
microbial contamination. It
is made from hydrophilic polyurethane
membrane matrix that is reinforced
for enhanced strength for use in deep
tunneling wounds. According
to Ferris Mfg. Corp., this reinforcement
helps to allow easy and complete removal
of the dressing at each dressing change.
PolyMem WIC Silver Rope
dressings can absorb up to six times
their weight
in exudate from the wound. There
are many PolyMem QuadraFoam dressing
configurations (with and without adhesive)
available for use as a cover dressing
with PolyMem WIC
Silver Rope.
All PolyMem QuadraFoam dressings contain
a mild nonionic, nontoxic tissue-friendly
cleansing agent, a moisturizer (glycerol),
and a superabsorbent starch copolymer. These
components allow PolyMem to continuously
cleanse and moisturize the wound while
in place. PolyMem QuadraFoam Silver
dressings contain small-particle silver
that releases silver ions as the dressing
absorbs moisture and exudate.
In vitro tests for antimicrobial effectiveness
have shown that PolyMem QuadraFoam Silver
dressings kill at least 99.9% of the
entire population of each organism tested.*
For
more information on PolyMem WIC Silver
Rope, contact
Ferris Mfg.
Corp.
16W300 83rd Street
Burr Ridge, IL 60527
phone: 800-POLYMEM (765-9636)
www.polymem.com *Organisms tested included Klebsiella
pneumoniae (ATCC# 4352), Pseudomonas
aeruginosa (ATCC# 9027), Enterococcus
faecalis (VRE) (ATCC# 51575), Candida
albicans (ATCC# 10231), Staphylococcus
aureus (MRSA) (ATCC# 33591) and Staphylococcus
aureus (ATCC#6538). The organisms chosen
demonstrate the antimicrobial actions
of the silver formulation on relevant,
representative organisms. |
Cymbalta Significantly
Reduced Osteoarthritis Knee Pain in
New Study
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In a new study, Cymbalta (duloxetine HCl) 60 -120 mg, taken once daily, reduced
pain severity significantly, compared with placebo, in patients with osteoarthritis
pain of the knee. Data from the 13-week randomized, double-blind, placebo-controlled
clinical trial were presented at the annual meeting of the American Academy
of Pain Medicine (AAPM) in Honolulu, Hawaii.
Duloxetine-treated patients showed greater reductions from baseline on the primary
endpoint, the 24-hour average pain score on the Brief Pain Inventory (BPI), compared
with placebo-treated patients. In the study, 65% of duloxetine-treated patients
experienced a clinically significant (at least 30%) improvement in pain, compared
with 44% of placebo-treated patients.
The duloxetine-treated patients also showed improved physical function, compared
with placebo-treated patients, as measured by the Western Ontario and McMaster
Osteoarthritis Index (WOMAC). In this study, patients on duloxetine did not show
statistically significant improvements on the WOMAC pain and stiffness subscales
compared with placebo.
The most common adverse events in the study (occurred at a rate of greater than
or equal to 5% and at least twice the rate of placebo) included nausea, constipation
and excessive sweating (hyperhidrosis). Adverse events were similar to those
seen in previous duloxetine studies.
Source: Eli Lilly |
Next-Generation
Grafting Material
|
Osteotech has announced its next generation grafting material will be marketed
under the brand name MagniFuse™ Bone Graft.
MagniFuse is a unique combination of allograft bone within a polymer mesh that
will provide targeted and contained delivery. The polymer mesh is made from a
biodegradable suture material and is designed for effective cellular in-growth
and complete resorption within 3 to 6 months, while not interfering with bone
regeneration. Osteotech notes that the polymer mesh provides a controlled environment
for proximate allograft interaction, eliminating issues with graft site migration
or irrigation that may be seen with currently available bone graft substitutes.
As previously announced, Osteotech has received 510(k) clearance from the US
Food and Drug Administration for MagniFuse as a bone graft substitute, and as
a bone void filler, for use in the spine, pelvis, and extremities.
Osteotech also has a patent-pending technology that controls the remodeling properties
of the allograft bone used in MagniFuse. MagniFuse is designed to be radiopaque,
allowing the surgeon to identify the bone graft in postoperative radiographs.
To learn more, contact
Osteotech
51 James Way
Eatontown, NJ 07724
phone 732-542-2800
www.osteotech.com |
Uni-Compartmental
Knee System
With Femur-First Option
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Cardo Medical notes that the Align
360 Uni-Compartmental Knee System,
its initial product release, has been
used successfully since its introduction
in January 2007. System enhancements
for the femur-first approach include
novel, unique femoral tibial alignment
("knee jack") instruments
with dedicated alignment and resection
guides.
Dr. Andrew Brooks, Chairman and Chief
Executive Officer of Cardo Medical,
states, "The Align 360 Uni-Compartmental
Knee system enables surgeons the flexibility
to choose between both a tibial-first
or femoral-first referencing and resection
surgical technique and approach. With
its innovative alignment and conservative
resection instrumentation, the system
easily adapts to any surgeons' training
and methodology, including use with
mechanical or computer-assisted surgical
navigation.”
The Align 360 Total Knee System’s
femoral component features a funnel-shaped
patella track that accommodates the
quadriceps angle anatomy for both male
and female patients. In addition, the
anterior geometry of the femoral component
is designed to reduce anteromedial
overhang of the femoral component.
Information on the Align 360 Uni-Compartmental
Knee System is available on the Web
at www.cardomedical.com.
For more information, contact
Cardo Medical
8899 Beverly Blvd,
Suite 619
Los Angeles, CA 90048
phone 310-274-2036
fax 310-861-5299
info@cardomedical.com |
Surgeon-Interactive
Tactile
Platform
| MAKO Surgical Corp.
has announced that it received 510(k)
clearances from the U.S. Food and Drug
Administration to market its proprietary
Version 2.0 Tactile Guidance System,
which is branded as the MAKO RIO™.
The MAKO RIO™ is a surgeon-interactive
tactile platform that incorporates
a robotic arm and patient-specific
visualization technology and prepares
the knee joint for the precise and
consistently reproducible insertion
and alignment of resurfacing implants
through a minimal incision. MAKO
notes that the TGS allows surgeons
to provide a tissue-sparing, bone-resurfacing
procedure called MAKOplasty® to
a large, yet underserved patient-specific
population suffering from early-
to mid-stage osteoarthritic knee
disease.
MAKO currently expects to commercially
launch both the RIO™ system
and and their bicompartmental knee
resurfacing implant system, the RESTORIS® MCK
system, in the first half of 2009.
For more information, contact
MAKO Surgical
Corp.
2555 Davie Road
Ft. Lauderdale, FL 33317
phone 954-927-2044
www.makosurgical.com |
Collagen
Meniscus Implant
| ReGen Biologics announced
the official US product launch of its
Menaflex™ collagen scaffold device.
The Menaflex is indicated for use in
surgical procedures for the reinforcement
and repair of soft-tissue injuries
of the medial meniscus. The device
is designed to guide new tissue growth
using the body’s own healing
process following removal of damaged
meniscus tissue. It provides
a resorbable scaffold for the growth
of new tissue in the meniscus.
An estimated 18 million partial meniscectomy
procedures have taken place in the
past 20 years. The incidence
of partial meniscectomies increases
for those patients who have had previous
procedures. Approximately 65%
of partial meniscectomies occur on
the medial meniscus.
The company plans to seek expansion
of the indication for use in the lateral
meniscus through a new 510(k) application
to be submitted to the FDA with data
from its ongoing European post-market
study.
For more information, contact
ReGen Biologics,
Inc.
411 Hackensack Avenue
Hackensack, NJ 07601
phone 201-651-5140
www.regenbio.com and www.menaflex.com |
Silicone
PIP Implant System
| Ascension Orthopedics,
Inc., a leader in orthopedic extremity
implants, announces the release of
the Ascension® Silicone PIP System
at the American Academy of Orthopaedic
Surgeons. The company notes that this
system features the smallest pre-flexed
silicone proximal interphalangeal (PIP)
implant offered in the orthopedic market
today.
The Ascension® Silicone PIP has
an anatomic pre-flexed design reproducing
the natural resting position of the
PIP joint and is designed to relieve
pain, restore motion, and improve the
cosmetic appearance of the joint. It
is available in six sizes with custom
color-coded instrumentation including
cutting broaches and a captured osteotomy
guide.
Ascension offers a full range of implants
for the MCP and PIP joints, both
in PyroCarbon and in Silicone.
For more information, contact
Ascension Orthopedics
8700 Cameron Road
Austin, Texas 78754
phone: (512) 836-5001
www.ascensionortho.com |
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