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NEWLY AVAILABLE, NEWLY APPROVED
Expanded Indications for
Surgery System
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PEAK Surgical, Inc., a medical device
company that has developed a new tissue-dissection
system based on a proprietary technology,
announced that the US Food and Drug
Administration (FDA) has granted the
company 510(k) clearance to market
its PEAK® Surgery System for cutting
and coagulation of soft tissue during
plastic and reconstructive, ear, nose,
and throat (ENT), gynecologic, orthopedic,
arthroscopic, spinal, and neurological
surgical procedures.
The PEAK Surgery System, which received
FDA clearance for use in general surgery
in July 2008, includes the PEAK PlasmaBlade™ family
of disposable surgical cutting and coagulation
devices. The PlasmaBlade tissue-dissection
devices are used in conjunction with
PEAK's PULSAR™ Generator, which
provides pulsed plasma radiofrequency
energy to the PlasmaBlade to incise
tissue and control bleeding. The company
notes that the PlasmaBlade offers the
exacting control of a scalpel and the
coagulation of traditional electrosurgery
without causing extensive collateral
damage. Since FDA clearance, surgeons
in the United States have used the PlasmaBlade
in nearly 350 surgical procedures, including
in general, gynecologic, cardiothoracic,
and plastic and reconstructive surgeries.
For more information, contact
PEAK Surgical,
Inc.
2464 Embarcadero Way
Palo Alto, CA 9430
phone (650) 331-3020
www.peaksurgical.com |
Dual Threaded Anchor System
|
DePuy Mitek, Inc., has announced the launch of the HEALIX™ BR Dual Threaded
Anchor System, the first suture anchor for arthroscopic rotator cuff repair made
with the company’s proprietary BIOCRYL® RAPIDE™ biocomposite
material. Shown in pre-clinical trials to resorb and promote bone formation within
the implant profile,1 the biocomposite material, exclusive to DePuy Mitek products,
has more than 4 years of clinical success in more than 100,000 patients, according
to the company.
HEALIX™ BR is an extension of the successful HEALIX™ PEEK family
of anchors. Both anchors are designed to independently engage cortical and cancellous
bone, maximizing pull-out strength and potentially minimizing re-tears. HEALIX
anchors are available in 3 sizes (4.5-mm, 5.5-mm, and 6.5-mm) to address a wide
variety of surgical techniques, and may be pre-loaded with ORTHOCORD, the company’s
high-strength suture.
BIOCRYL RAPIDE has shown, in preclinical models, marked absorption and a proliferation
of bone cells after 18 months, with near total absorption in about 24 months.1
For more information, contact
DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767
phone (800) 382-4682
www.depuymitek.com
1. Pre-clinical study. Data on file at DePuy Mitek, Inc. |
Posterior Fixation
System
|
VertiFlex®, Inc., a privately held medical device company specializing in
percutaneous, minimally invasive, and motion preservation technologies for treating
disorders of the spine, has announced the launch of Silverbolt™ Plus, a
posterior fixation system designed to support all types of surgical approaches
in the lumbar spine—percutaneous, mini-open, and open—in one single
instrument set.
The company notes that Silverbolt™ Plus gives surgeons a complete solution
for posterior lumbar fixation, with access to a variety of instrumentation options—percutaneous
delivery of single and multiple vertebral levels, percutaneous dynamic stabilization
with the Dynabolt™ Dynamic Rod, and supplemental instruments for mini-open
and open approaches.
For more information, contact
VertiFlex, Inc.
1351 Calle Avanzado
San Clemente, CA 92673
phone (866) 268-6486
www.vertiflexspine.com |
Fibromyalgia
Management Treatment
| Forest Laboratories,
Inc., and Cypress Bioscience, Inc.,
today announced that Savella™ (milnacipran
HCl), a selective serotonin and norepinephrine
dual reuptake inhibitor, was approved
by the US Food and Drug Administration
for the management of fibromyalgia.
The safety and efficacy of Savella
was established in two US pivotal phase
III clinical trials involving over
2,000 patients with fibromyalgia. The
studies showed that Savella doses of
100 mg/day and 200 mg/day demonstrated
statistically significant and clinically
meaningful concurrent improvements
in pain, patient global assessment,
and physical function.
Although the exact mechanism by which
Savella improves the symptoms of fibromyalgia
is unknown, some researchers believe
that abnormalities in certain brain
neurotransmitters may be central to
fibromyalgia. Savella blocks the reuptake
of both norepinephrine and serotonin,
with greater selectivity for the inhibition
of norepinephrine reuptake in vitro.
The companies note that this may be
the mechanism by which Savella acts
to improve the symptoms of fibromyalgia.
For more information on Savella, contact
Cypress Bioscience,
Inc.
4350 Executive Drive, Suite 325
San Diego, CA 92121
phone (858) 452-2323
www.cypressbio.com |
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