|
NEW PRODUCTS / PRODUCT NEWS
CORTOSS™ Approved
for Vertebral Compression Fractures
|
Orthovita, Inc., has announced that
it received 510(k) clearance from
the US Food and Drug Administration
(FDA) to market CORTOSS™ Bone
Augmentation Material for treatment
of vertebral compression fractures.
CORTOSS is an injectable, bioactive
composite that mimics the physiological
properties of human cortical bone and
is the first alternative to polymethylmethacrlyate
(PMMA) cement that has been evaluated
in a large-scale, multicenter, randomized,
controlled clinical study and cleared
in the United States for the treatment
of vertebral compression fractures.
In April 2009, Orthovita submitted the
2-year follow-up clinical data for patients
enrolled in the company’s prospective,
randomized, multicenter study comparing
the efficacy of PMMA to CORTOSS. In
this 256-patient trial conducted under
an investigational device exemption,
CORTOSS achieved its primary endpoint
of noninferiority to the PMMA control
at 24 months, using a composite endpoint
success rate reflecting improvement
in the Visual Analogue Pain Scale (VAS)
pain score, maintenance or improvement
in Oswestry Disability Index (ODI) function
assessment, maintenance of vertebral
height and alignment, and no subsequent
device-related surgical intervention
at the index treatment level. At 24
months, the composite endpoint success
rate was 76.9% for patients treated
with CORTOSS and 73.4% for PMMA patients.
With an ODI success rate of 96.7%, the
CORTOSS patient group experienced a
statistically significant benefit in
function success over the PMMA group,
which had an ODI success rate of 88.4%.
Early patient outcomes were also assessed
in the pivotal study at 3 months: The
composite endpoint success rate was
82.8% for patients treated with CORTOSS
and 73.7% for PMMA patients. With a
VAS success rate of 86.6%, the CORTOSS
patient group experienced a statistically
significant benefit in pain success
over the PMMA group, which had a VAS
success rate of 75.0%.
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
Orthovita
77 Great Valley Parkway
Malvern, PA 19355
phone (610) 640- 1775
fax (610) 640-2603
www.orthovita.com
|
Cervical Disc System Approved
|
Medtronic, Inc., announced that it has received FDA approval to market the BRYAN® Cervical
Disc System for the treatment of single-level cervical disc disease (radiculopathy
and/or myelopathy).
The BRYAN® Cervical Disc is a titanium-polyurethane prosthetic device that
is inserted between the vertebrae to replace the natural spinal disc. Medtronic
notes that the BRYAN® Cervical Disc is designed to maintain range of motion
in the neck, which the potential alternative anterior cervical discectomy and
fusion (ACDF) does not. With the ACDF, the diseased disc is removed and the empty
space is fused using a bone graft with a plate and bone screws, which eliminates
the range of motion in the operated segment of the neck. The BRYAN® Cervical
Disc is designed to allow for motion of the cervical spine, including flexion/extension,
lateral bending, axial rotation, and translation.
For more information, contact
Medtronic
710 Medtronic Parkway
Minneapolis, MN 55432
phone (763) 514-4000
fax (763) 514-4879
www.medtronicspinal.com |
Spacer System Launched
|
Globus Medical, Inc., has announced the launch of the COALITION™ ACDF
Spacer System. COALITION™ is an integrated plate and spacer system designed
to provide the biomechanical strength of a traditional ACDF with less disruption
of patient anatomy and a preserved anatomical profile.
The COALITION technology combines a PEEK interbody spacer with a titanium alloy
plate and 2 titanium alloy screws. The company notes that the streamlined delivery
system and innovative 2-screw design reduces procedural steps, minimizes retraction,
and lags the spacer to the vertebral endplates to compressively load the fusion
area.
The COALITION system is designed to address a wide variety of surgical situations
and preferences. The system offers 3 anatomical footprints, 2 sagittal profiles,
and fixed- and variable-angle screws in both self-drilling and self-tapping
options.
The COALITION ACDF Spacer System is the latest addition to Globus Medical’s
MILDER™ Spine Care portfolio. MILDER (Minimally Invasive, Less Disruptive,
Earlier Recovery) Spine Care encompasses a holistic approach to spine care
that integrates minimally invasive surgical techniques with implants, instrumentation,
and education designed to lessen the disruption to a patient’s anatomic
structures and natural range of motion in order to facilitate an earlier, pain-free
recovery.
To learn more, contact
Globus Medical, Inc.
Valley Forge Business Center, 2560 General Armistead Avenue
Audubon, PA 19403
phone (610) 415-9000
fax (610) 415-9144
www.globusmedical.com
|
Cymbalta® for
Chronic Pain
|
Eli Lilly and Company has resubmitted
its supplemental New Drug Application
(sNDA) for Cymbalta® (duloxetine
HCl) for the management of chronic
pain to the FDA. Lilly’s
resubmission is based on a recently
completed study in chronic pain
due to osteoarthritis, the extension
phase of a chronic low back pain
study, and previously completed
studies in pain due to osteoarthritis
and chronic low back pain. The
application is supported by studies
in diabetic peripheral neuropathic
pain and fibromyalgia.
Based on preclinical studies, Cymbalta
is a potent reuptake inhibitor of serotonin
and norepinephrine. Although the exact
way that Cymbalta works in people is
unknown, it is believed to be related
to an increase in the activity of serotonin
and norepinephrine. Cymbalta is approved
in the United States for the acute
and maintenance treatment of major
depressive disorder, the acute treatment
of generalized anxiety disorder, the
management of diabetic peripheral neuropathic
pain, and the management of
fibromyalgia, all in adults. Cymbalta
is not approved for use in
pediatric patients.
For more information, contact
Eli Lilly
Lilly Corporate Center
Indianapolis, IN 46285
phone (317) 276-2000
For full prescribing information, including boxed warning and medication
guide, visit
www.cymbalta.com |
Postmenopausal
Osteoporosis Prevention
| Reclast® (zoledronic
acid 5 mg) Injection has been approved
by the FDA as the first and only
therapy to prevent postmenopausal
osteoporosis for 2 years with a single
dose.1 Reclast, or Aclasta® as
it is known outside the United States
(US), is already approved in more
than 80 countries including the US
and European Union (EU) as a once-yearly
infusion for the treatment of postmenopausal
osteoporosis.1,2
The FDA decision is based on a study
involving more than 500 postmenopausal
women with osteopenia, or low bone
mass, showing that a single infusion
of Reclast significantly increased
bone mineral density (BMD) at 2 years
compared with placebo.1
Reclast is already approved in the
US as a once-yearly infusion to treat
postmenopausal osteoporosis, to increase
bone mass in men with osteoporosis,
and to treat and prevent osteoporosis
caused by glucocorticoids. In the EU,
Aclasta is approved for the treatment
of osteoporosis in postmenopausal women
and in men at increased risk of fracture,
including those with a low-trauma hip
fracture.2 Additionally, the Committee
for Medicinal Products for Human Use
(CHMP) has issued a positive opinion
recommending Aclasta for the treatment
of glucocorticoid-induced osteoporosis
in the EU. Aclasta/Reclast is also
approved in the US and EU for the treatment
of Paget’s disease of bone, the
second most common metabolic bone disorder,
in men and women.1,3
The new US indication to prevent bone
loss in postmenopausal women with osteopenia
was based on a 2-year randomized, multicenter,
double-blind, placebo-controlled study
of 581 postmenopausal women older than
45 years of age. The primary endpoint
was the change in BMD at 2 years relative
to baseline.1 This study included women
in early menopause (ie, within 5 years
of menopause) and late menopause (ie,
more than 5 years from menopause).1 Patients were divided into 3 groups
and received either Reclast at the
beginning of the study and again at
1 year, Reclast at the beginning of
the study and placebo at 1 year, or
placebo at the beginning of the study
and placebo again at 1 year.1 Reclast
significantly increased lumbar spine
BMD relative to placebo at the end
of the 2-year study.1 Treatment with
Reclast given as a single dose at the
beginning of the study increased lumbar
spine BMD by 6.3% in the early menopause
group and by 5.4% in the late menopause
group at two years (both P<0.0001).1
To learn more, contact
Novartis Pharmaceuticals
Corporation
One Health Plaza
East Hanover, NJ 07936-1080
phone (862)778-8300
fax (973)781-8265
www.pharma.us.novartis.com
References
|
Total
Ankle Replacement System
|
Small Bone Innovations, Inc. (SBi), announced
that the FDA has approved SBi’s Scandinavian
Total Ankle Replacement (S.T.A.R.®)
system to treat US patients. S.T.A.R.® has
received pre-market approval (PMA) to replace
a painful arthritic ankle joint due to
osteoarthritis, posttraumatic arthritis,
or rheumatoid arthritis.
S.T.A.R. has more than 19 years of clinical
experience, and the current design has
been implanted in over 15,200 patients
worldwide. Additionally, there have been
35 peer-reviewed clinical outcomes papers
published on S.T.A.R.®; SBi believes
that this number of papers is more than
on any other mobile-bearing total ankle
arthroplasty device.
A US Investigational Device Exemption (IDE)
Clinical Trial of S.T.A.R.® was initiated
in August 2000 as a prospective, multicenter,
controlled study to compare the safety
and efficacy of S.T.A.R. with ankle fusion
(the current standard of care). The study,
which followed patients for a minimum of
24 months, is the only US IDE clinical
trial to have been completed on a 3-piece,
mobile-bearing, nonconstrained, uncemented
total ankle replacement system. More than
670 patients were enrolled in the pivotal
and continued-access phases of the IDE
clinical trial. S.T.A.R.® is the only
FDA-approved total ankle replacement system
for uncemented use.
For more information, contact
Small Bone Innovations,
Inc.
1380 S. Pennsylvania Avenue
Morrisville, PA 19067
phone (215) 428-1791
fax (215) 428-1795
www.totalsmallbone.com |
NUCYNTA™ (tapentadol)
CII Immediate-Release Tablets
Now Available
for Relief of Moderate to Severe Acute Pain
|
PriCara®, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., has announced that
NUCYNTA™ (tapentadol) CII immediate-release
tablets are now available for use in the
relief of moderate to severe acute pain
in patients 18 years of age or older, by
prescription only, in 50-mg, 75-mg, and
100-mg doses.
NUCYNTA™ binds to mu-opioid receptors
and inhibits norepinephrine re-uptake.
Although the exact mechanism of action
is not known, these two mechanisms, which
affect established pain pathways, are thought
to be responsible for pain relief with
NUCYNTA.™ “In clinical trials,
NUCYNTA™ provided patients with effective
pain relief and was shown to have fewer
of the gastrointestinal side effects often
reported with prescription pain medications
that act on mu-opioid receptors,” said
Perry Fine, MD, Professor of Anesthesiology,
University of Utah, Salt Lake City, and
consultant to PriCara.
On November 20, 2008, the FDA approved
NUCYNTA™ for the relief of moderate
to severe acute pain in patients 18 years
of age or older. The US Drug Enforcement
Agency has placed NUCYNTA™ into Schedule
II of the Controlled Substances Act.
The FDA approval of NUCYNTA™ was
based on data from clinical studies involving
more than 2,100 patients with acute pain.
The studies found that NUCYNTA™ provided
significant relief of moderate to severe
acute pain compared with placebo.
Multiple Phase 3 studies presented at the
27th Annual Scientific Meeting of the American
Pain Society in May 2008 found that NUCYNTA™ offered
patients significant relief of their pain
when compared with placebo and that the
medicine was generally well tolerated in
these studies. The studies were published
in peer-reviewed journals.
Patients with different pain conditions
participated in the NUCYNTA™ Phase
3 clinical studies: those who had a bunionectomy,
those with pain from end-stage joint disease
of the hip or knee, and those with low
back pain.
An additional Phase 3 clinical study published
in the June 2009 issue of the journal Current
Medical Research and Opinion found that
NUCYNTA™ at 50 mg provided patients
with equivalent efficacy in pain relief
following orthopedic surgery and significant
reduction in composite incidence of nausea
and/or vomiting compared with 10 mg of
oxycodone IR.
To read the NUCYNTA™ full prescribing
information, go to http://www.pricara.com/pricara/pages/products_list.jsp or www.NUCYNTA.com.
Contact PriCara®, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., at www.PriCara.com (for immediate assistance, the Customer
Communication Center can be reached by
phone at: 1-800-526-7736, 9:00 am - 5:00
pm (EST), Monday through Friday). |
Magnesium-Based
Bone Void Filler
|
Bone Solutions, Inc. (BSI) announced
it has received US FDA 510(k) clearance
for OsteoCrete™, a biocompatible
magnesium-based bone void filler that is
resorbable, injectable, osteoconductive,
and nontoxic.
Both injectable and moldable, OsteoCrete™ is
indicated for bony voids or defects that
are not intrinsic to the stability of the
bony structure. OsteoCrete™ is intended
to be placed or injected into bony voids
or gaps of the skeletal system (the long
bone and pelvis). These defects may be
surgically created osseous defects or osseous
defects created from traumatic injury to
the bone. OsteoCrete™ provides a
bone void filler that resorbs and is replaced
with bone during the healing process.
OsteoCrete™ utilizes a similar material
composite noted in the patent that the
FDA cleared for long-bone and pelvis applications.
BSI believes that its magnesium-based technology
has the potential to improve the success
rates of long-bone and pelvis surgeries
that could revolutionize future bone and
ligament surgical operations for human
applications worldwide. The company believes
that future research with its magnesium-based
platform will, at a minimum, augment—and
potentially replace—some of the screws,
pins, and plates now used for major knee
and shoulder surgeries, for more rapid
recoveries.
For more information, contact
Bone Solutions, Inc.
10,000 North Central Expwy, Suite 900
Dallas, TX 75231
phone (214) 234-0661
fax (800) 417-8196
www.bonesolutionsinc.com |
|
