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NEWLY AVAILABLE, NEWLY APPROVED
Vertebral Augmentation
System and ER Bone Cement
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DFine, Inc., a developer of minimally
invasive solutions for treating vertebral
compression fractures (VCFs), announced
the launch of its StabiliT™ Vertebral
Augmentation System and StabiliT™ ER
Bone Cement. The StabiliT Vertebral
Augmentation System allows for on-demand
controlled delivery of a cohesive
ultra-high viscosity cement in vertebral
augmentation procedures.
The DFine technology allows physicians
to control the viscosity of the StabiliT
ER Bone Cement, a proprietary energy-responsive
polymethylmethacrylate (PMMA) formulated
cement, through the application of radiofrequency
energy. The physician can change the
bone cement viscosity on demand, delivering
an ultra-high viscosity, yet flowable,
cement that forms an internal cast for
stabilizing the fracture. The process
can yield height elevation of the collapsed
vertebrae while minimizing leakage of
bone cement (extravasation).
The StabiliT Vertebral Augmentation
System enables simultaneous cavity creation
and filling. The company notes that
the high viscosity of the cement may
address the patient’s fracture
with greater specificity through localized
delivery of cement to compromised structures.
DFine observes that its streamlined,
cost-effective solution for vertebral
augmentation allows the physician to
perform a one-step procedure and makes
a single percutaneous injection site
possible. The ultra-high viscosity cement
can be delivered over an extended period
of time, which enables physicians to
work on multiple vertebrae with one
kit.
For more information, contact DFine,
Inc.,
DFine,
Inc.
3047 Orchard Parkway
San Jose,
CA 95134
phone (866)963-3463
www.dfineinc.com |
Demineralized Bone Matrix
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Integra LifeSciences Holdings Corporation announced it has received 510(k) clearance
from the US Food and Drug Administration to market Accell Evo3™ in the
United States.
Accell Evo3™ is the latest generation in demineralized bone matrix and
is composed of an optimized blend of particulate Demineralized Bone Matrix (DBM),
the proprietary Accell® Bone Matrix (ABM), and a unique poloxamer Reverse
Phase Medium. The poloxamer Reverse Phase Medium is a thermo-reversible carrier
that thickens at body temperature and is more flowable at room temperature.
Accell Evo3™ contains more of the patented Accell® Bone Matrix than
Integra’s previous generation Accell® products. The company notes that
the optimized platform of Accell Evo3™ enables the bone healing process
to take advantage of the naturally available bone proteins found in DBM and ABM.
Accell Evo3™ has been specifically formulated to provide surgeons with
the best possible intraoperative handling characteristics for proper utilization
of the graft material and is marketed in combination with a new custom-designed
open-bore syringe.
Integra notes that Accell Evo3™ may be used as a bone graft extender in
the spine, extremities, and pelvis or as a bone void filler for the extremities
and pelvis and may replace the need to harvest bone graft material from the iliac
crest, thus sparing the patient additional surgery and postoperative pain.
To learn more, contact Integra at
Integra
311 Enterprise Drive
Plainsboro, NJ 08536
phone (609)275-0500
www.Integra-LS.com |
Interspinous
Process
Decompression
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Medtronic, Inc., announced the US launch of the X-Stop PEEK Interspinous Process
Decompression (IPD) System, the first interspinous process decompression device
approved by the US Food and Drug Administration that offers a PEEK-Bone interface
for treating the symptoms of lumbar spinal stenosis (LSS).
Polyetheretherketone (PEEK) polymer, a biomaterial widely accepted for spinal
applications, provides several benefits such as biocompatibility and radiolucency. Medtronic’s
launch of the PEEK version, the second generation of the X-Stop system, gives
spine surgeons the option of using this material in IPD procedures
The X-Stop PEEK system is a minimally invasive treatment of the symptoms of LSS. The
company notes that the X-Stop PEEK implant has been designed to be more elliptical
than the first-generation X-Stop device. This shape increases the contact
area with bone by 30% compared with an implant of circular cross section. There
is a broader load-bearing surface for distributing loads to the spinous processes,
thereby decreasing contact
pressures.
Medtronic has also extended its product offering of X-Stop implant sizes with
the addition of the 16-mm implant in the PEEK system. This larger implant
size has been requested by spine surgeons for some of their patients. Medtronic
will continue to offer both the titanium and PEEK versions of the X-Stop system.
For more information, contact Medtronic,
Medtronic
710 Medtronic Parkway
Minneapolis,
MN 55432
phone (763) 514-4000
www.medtronic.com |
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