|
NEW PRODUCTS / PRODUCT NEWS
Single-Injection
Viscosupplementation
|
Genzyme Corporation announced on February
26, 2009, that the US Food and Drug
Administration has granted marketing
approval for Synvisc-One™ (hylan
G-F 20), a product intended for the
relief of pain associated with osteoarthritis
of the knee. Synvisc-One is the only
single-injection viscosupplement approved
for the treatment of OA knee pain
in the United States.
Synvisc-One is administered through
a single intra-articular injection.
It is an alternative treatment regimen
to Genzyme’s Synvisc® (hylan
G-F 20), a 3-injection viscosupplement
approved in the United States in 1997
and in use worldwide for more than 16
years. Synvisc-One contains the same
material and total treatment volume
as Synvisc but provides the 6 mL of
hylan G-F 20 in a single injection.
Synvisc-One is also approved in the
European Union and a number of Asian
and Latin American countries. Nearly
10,000 patients have been treated with
Synvisc-One since it was first approved
last year. Full prescribing information
is available at www. synvisc-one.com
.
To
learn more, contact
Genzyme Corporate
Offices
500 Kendall Street
Cambridge, MA 02142
phone: (617) 252-7500
www.genzyme.com
|
Biotherapeutic Thermogels
|
BioSyntech, Inc., a biotechnology company developing biotherapeutic thermogels
for regenerative medicine, announced that it will conduct an interim analysis
of the available clinical data from 40 subjects who have completed their 12-month
follow-up in the 80-subject trial for its cartilage repair device, BST-CarGel®.
The company expects to have the results from this analysis available in the
second quarter of 2009.
The ongoing, randomized BST-CarGel® pivotal trial compares the treatment
of cartilage lesions using BST-CarGel® applied following microfracture to
treatment with microfracture alone as a control. The trial enrolled 80 subjects
aged 18 to 55 years with focal cartilage lesions less than 10 cm2 located on
the femoral condyles of the knee. Subjects were further stratified by their lesion
type, either acute (ie, traumatic) or chronic (ie, degenerative). The primary
endpoint for this trial is cartilage repair at 12 months, defined by the quantity
and quality of the repaired tissue as measured with quantitative magnetic resonance
imaging. Secondary endpoints are safety and knee-related pain, stiffness, and
function as measured using the Western Ontario and McMaster Universities (WOMAC)
osteoarthritis index questionnaire.
BioSyntech’s platform technology is a family of hydrogels called BST-Gel®,
some of which are liquid at low temperature and solid at human body temperature.
The company notes that these gels can be injected or applied to a specific local
site and offer beneficial properties for the local repair of damaged tissue such
as cartilage, bone, and chronic wounds and provide the benefit of avoiding invasive
surgery.
For additional information, visit www.biosyntech.com |
Adult Stem Cell–Based
Allograft
|
Orthofix International N.V. announces that the expected launch of Trinity® Evolution™ the
next-generation adult stem cell–based allograft developed
in collaboration with the Musculoskeletal Transplant Foundation (MTF), has been
accelerated to May 1, 2009, two months ahead of schedule.
Trinity Evolution is
an adult stem cell–based bone growth matrix designed to advance the surgical
use of allografts by providing characteristics similar to an autograft used in
spinal and orthopedic surgeries.
For more information, contact
Orthofix International NV
The Storrs Building, Suite
250
10115 Kincey Avenue, Huntersville Business Park
Huntersville, NC 28078
phone (704) 948-2600
www.orthofix.com |
Acetabular
Cup System
Metal Liner
Option
|
Smith & Nephew, Inc., Orthopaedic
Reconstruction & Trauma, announced
the introduction of a metal liner option
for its R3 Acetabular System, an advanced
multi-bearing acetabular cup system
used in hip replacement and resurfacing
procedures.
The metal liner was recently approved
by the US Food and Drug Administration
(FDA) for use with the Birmingham Hip™ Resurfacing
(BHR™) System. Since March 2008,
the R3 system has been fitted with
cross-linked polyethylene (XLPE) liners
for use in total hip replacement cases,
and Smith & Nephew has received
FDA approval of its ceramic liner option.
The company notes that it is the only
acetabular system available to surgeons
that accommodates the major advanced
bearing options, including metal-on-metal,
ceramic-on-ceramic, cobalt chrome–on–cross-linked
polyethylene (XLPE), and the company’s
Oxinium™ Oxidized Zirconium–on–XLPE.
Smith & Nephew emphasizes that the multi-bearing cup, in addition to providing
intraoperative flexibility for surgeons, provides solutions designed to reduce
wear and the subsequent need for revision surgery. Its range of inserts accommodates
larger head sizes and is optimized to help the R3 system achieve joint stability
and a greater range of motion. By utilizing disposable trial liners and a single
set of instruments for all bearings, the R3 Acetabular System aims to give surgeons
simplicity in the operating room and confidence in a stable, multi-bearing system.
In tests, the R3 Acetabular System’s proprietary Stiktite™ porous
coating demonstrated a higher coefficient of friction than trabecular metal on
both cancellous and cortical bone, indicating the potential for superior scratch-fit
feel and initial fixation. Additionally, Smith & Nephew notes that the R3
system is enhanced by a proprietary hard-bearing alignment guide—a thin
plastic shield resembling a disposable coffee cup lid that enables surgeons to
simply and accurately place a ceramic or metal liner into the shell during surgery.
This technique is intended to reduce the risk of improper seating and malalignment.
For more information, contact
Smith & Nephew
Orthopedics, Inc.
1450 E. Brooks Road
Memphis, TN 38116
phone (901) 396 2121
www.smith-nephew.com
|
Bioabsorbable
Labral Tear
Solution
| Smith & Nephew’s
Endoscopy Division has announced the
launch of the Osteoraptor™ Anchor
for repair in the hip and shoulder.
During 2009, surgeons will perform
an estimated 15,000 labral repair procedures
in the hip joint and an estimated 185,000
procedures for the shoulder. Smith & Nephew
Endoscopy Division notes that the new
Osteoraptor Anchor is the first hip
anchor to use polylactic acid hydroxyapatite
(PLLA-HA) and that the key ingredient,
hydroxyapatite (HA), is a mineral found
naturally in bone. Studies have shown
that the presence of HA increases the
anchor’s strength and introduces
chemicals that promote the formation
of a strong bond between the anchor
and the bone surface.1
The anchor is available in 2.3-mm and
2.9-mm sizes. The company notes that
the Osteoraptor 2.3-mm Anchor for use
in the hip is the smallest bio-absorbable
hip anchor on the market. Typically,
surgeons use multiple anchors to repair
labral tears. The anchors’ size
gives the surgeon the ability to place
them more precisely within the tight
confines of the joint space.
Based on surgeon feedback, the Osteoraptor
Anchor system incorporates many features
of the previously released Bioraptor™Anchor
line—including the implant rib
design and the instrumentation used
to deliver the implant. Because they
are molded from bioabsorbable PLLA-HA,
the anchor is invisible on radiographs
and does not distort images captured
using magnetic resonance imaging.
To learn more, contact
Smith & Nephew,
Inc.
150 Minuteman Road
Andover, MA 01810
phone (978) 749-1000
www.smith-nephew.com
1. Landor I, Vavrik P, Sosna A,
Jahoda D, Hahn H, Daniel M. Hydroxyapatite
porous coating and the osteointegration
of the total hip replacement. Arch
Orthop Trauma Surg. 2007;127(2):81-89.
Epub 2006 Sep 30. |
Cream For Pain Relief
| RZN Nutraceuticals
has developed a medicated and clinically
tested analgesic Arthri-Zen Relief
Cream®. The company notes that
a recent randomized, blinded study
recruited 83 adults with physician-diagnosed
arthritis, all of whom had had a history
of daily arthritis pain for a minimum
of 6 months. For 10 days, study subjects
applied Arthri-Zen Relief Cream® to
joint “hot spots” 3 times
a day. They were evaluated by a clinician
on the 1st day and again on the 10th
day for conditions such as arthritis,
inflammation, swelling, joint stiffness,
muscle pain, and range of motion. Throughout
the study, participants also kept daily
pain diaries.
Overall, 63% of study subjects got
relief from swelling, 93.8% experienced
an increase in range of motion, 94.1%
got relief from arthritis and inflammation,
and a full 100% had relief from muscle
pain and joint stiffness. All of the
results were statistically significant.
RZN Nutraceuticals points out also
that after 5 minutes, more than 25%
of participants experienced 90%-100%
relief from their pain. Another 41.3%
got 70%-89% relief. And another 22.5%
had 50%-69% relief. Arthri-Zen Relief
Cream® provided relief from arthritis
aches and pains for up to 8 hours.
Arthri-Zen Relief Cream® contains
the OTC pain-relieving ingredient menthol,
as well as RZN Nutraceuticals’ herbal
formula including extracts of juniper,
goldenrod, dandelion, meadowsweet,
and willow bark. The ingredients are
delivered in a base with moisturizing
conditioners such as aloe, shea butter,
avocado, and grape seed oil.
Arthri-Zen Relief Cream® is intended
for use by those with arthritis and
also by athletes to relieve the pain
of backaches, sprains, bruises, strains,
and stiffness. Currently, Arthri-Zen
Relief Cream® is only available
direct through the company’s
Web site or by phone.
For more information, contact
RZN Nutraceuticals
1279 Kingsley Ave, Ste 101
Orange Park, FL 32073
phone 904-213-8232
www.rznnutra.com |
|
