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NEWLY AVAILABLE, NEWLY APPROVED
Low-Profile Pedicle Screw System
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Scient’x USA announced the receipt
of 510K clearance to market their new
Isobar LP® Low Profile Pedicle Screw
System. The Isobar LP® System offers
a top-loading tulip-head design with
an inner locking set screw to offer
more space in the construct. The screws
feature a self-tapping design and are
available in a wide variety of diameters
and lengths for thoracic, lumbar, and
sacral areas. This pedicle screw system
works in conjunction with the other
components in the Isobar TTL system,
including the EASYS Crosslink and Dynamic
TTL-Rod, which provides controlled micromotion
in compression, distraction, flexion,
extension, and rotation. The Isobar
LP Pedicle Screw System offers surgeons
the option to use a smaller, lower-profile
screw that, notes Scient’x, allows
more space in the overall construct
when used with the Dynamic TTL-Rod.
To learn more, contact
Scient’x USA
1015 Maitland Center Commons, Suite 106A
Maitland, FL 32771
Phone (407)571-2550
Fax (407)571-2551
www.scientxusa.com |
Portable Cold Therapy System
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VQ OrthoCare has announced the addition of the VQ CoolCare™ cold therapy
system to its product offering. VQ CoolCare’s portable design features
a motorized unit that helps reduce pain and swelling by providing patients with
up to 7 hours of safe and effective continuous cold therapy. Consistent temperature
control throughout the cooling pad is achieved through a semi-closed loop system
that allows warm water to re-circulate at a constant flow rate with cooler water.
For ease of patient use, VQ CoolCare also provides a single, easy-to-operate
control; lightweight, spill-resistant design; and eight-quart capacity.
For more information, contact
VQ OrthoCare
18011 Mitchell South
Irvine CA 92614
Phone (800)266-6969
Fax (800)821-8012
www.vqorthocare.com |
Radial Head Replacement System
Wright Medical Group, Inc. announced the launch
of its EVOLVE® PROLINE Radial Head System for radial
head replacement. The EVOLVE® PROLINE System is
the latest advance of Wright’s
EVOLVE® Radial Head Prosthesis, which is used to
address instability in complex elbow fractures.
Wright notes that the EVOLVE® PROLINE Radial Head System builds
upon the success of the EVOLVE® Radial Head Prosthesis with new
in-situ assembly capability. This allows the implant to be inserted
without surgical dissection of intact elbow ligaments, reducing the
invasiveness of the procedure. Additional implant sizes are said
to enable the surgeon to address both the radiocapitellar joint (RCJ)
and the proximal radioulnar joint (PRUJ) independently. The company
notes that conventional designs attempt to address the RCJ but do
not permit anatomic flexibility in addressing the PRUJ. Over 16,000
EVOLVE® Radial Head prostheses have been implanted since the
product’s inception.
To learn more, contact
Wright Medical Group
5677 Airline Road
Arlington TX 38002
Phone (800) 238-7117
Fax (901)867-9534
www.wmt.com |
von Willebrand Disease Treatment
Grifols, a global healthcare company specializing
in biologic therapies derived from human plasma, announced that
it has received approval from the U.S. Food and Drug Administration
to market Alphanate® for the treatment of congenital von Willebrand
Disease (VWD) in connection with orthopedic surgeries and other
invasive procedures. Grifols notes that Alphanate® is the first
and only dual-inactivated (solvent detergent and heat treatment)
and affinity chromatography–purified antihemophilic factor/von
Willebrand factor complex that is FDA approved for the treatment
of VWD. Dual-inactivated Alphanate® has been proven safe and
effective for the treatment of hemophilia
A through more than a decade of use.
Grifols obtained FDA approval for the
use of Alphanate® in the treatment of VWD on the basis of prospective
and retrospective clinical data to evaluate the safety and efficacy
of the therapy in treating VWD patients undergoing invasive procedures,
including surgery. Clinical data submitted in support of the VWD
indication for Alphanate® included data from 76 patients, including
both pediatric and female patients, who underwent surgery or other
invasive procedures.
For more information and to review the prescribing information for
Alphanate®, contact
Grifols, Inc.
2410 Lillyvale Avenue
Los Angeles, CA 90032-3514
Phone (800)421-0008
www.grifolsusa.com |
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