Advanced
Biomaterial Systems Receives CE Mark for Plexis® Bone
Void Filling System and Concert® Spine VR Bone Cement
Products
Advanced
Biomaterial Systems Receives ISO 13485:2003 Certification
Chatham,
NJ, January 23, 2006
Advanced Biomaterial Systems, Inc. (ABS) received US patent
6,984,063 for an Apparatus for Mixing and Dispensing Components.
This patent is a continuation of several patents which incorporate
twistOR® and Plexis® technology. The mixing and
dispensing capability of this device provides unequalled
control in minimally invasive techniques such as vertebroplasty
and kyphoplasty. The next generation technology encompasses
the delivery of unique medical polymers for soft tissue
intervention. Additional United States and International
patents are pending.
Additionally,
ABS received CE Mark approval for its Plexis® Bone Void
Filling System and Concert® Spine VR Bone Cement products.
“The CE Mark demonstrates that the company is in compliance
with the regulatory requirements of Medical Devices Directive
(93/42/EEC) and allows the company to market the device
in any European Union member country and in other selected
international markets,” said Forrest Rudnick, ABS
Vice President Quality Assurance. “The certification
of a quality management system, specifically for the manufacture
of products covered by the new Approach EC Directives, is
essential for ABS to export products to the global market.”
The
Plexis® Bone Void Filling System in conjunction with
Concert® Spine VR Bone Cement provides physicians the
ability to treat vertebral compression fractures with precise
control of radiopaque bone cement. “In addition to
allowing for extended working time, Concert® Spine VR
Bone Cement provides the consistency of a smooth, silky
paste, deliverable through a 15 gauge cannula, from initial
dispensing to depletion” states Roy Bogert, ABS Vice
President of R&D. “Unlike other bone cements altered
from orthopaedic indications, Concert® Spine VR Bone
Cement was specifically developed to address the concerns
and requirements pertaining to the minimally invasive treatment
of vertebral compression fractures. The design capabilities
of the Plexis® device provide a delivery means that
is minimally invasive while maintaining polymers or other
materials in controlled suspension for precise qualitative
and quantitive placement.”
Finally,
ABS received ISO 13485:2003 Certification for medical device
design and manufacturing. “The achievement of ISO
certification designates a corporate commitment to quality
in the design and manufacture of medical devices that involves
all levels of an organization,” states Forrest Rudnick,
ABS Vice President Quality Assurance. “This certification
demonstrates the on-going commitment at ABS to providing
the highest quality products and services to our clients.”
About Advanced Biomaterial Systems, Inc.
Advanced
Biomaterial Systems (www.advbiomat.com) develops and markets
proprietary biomaterials and delivery systems designed to
advance procedure outcomes and patient safety. ABS products
include: twistOR PrePack® - a patented mixing and delivery
system prepackaged with ABS proprietary CONCERT® Bone
Cement used for the fixation of prostheses to living bone
in orthopaedic musculoskeletal surgical procedures; Plexis®
Bone Void Filling System – a mixing and delivery system
based on patented technology used for delivering biomaterials
to site specific locations in minimally invasive procedures;
CONCERT® Spine VR Radiopaque Bone Cement – a proprietary
material used for the fixation of pathological fractures
of the vertebral body in either vertebroplasty or kyphoplasty
procedures; and CONCERT® Cranioplast - a proprietary
radiopaque resinous material used for repairing cranial
defects.
Contact: Matthew J. Carr
Business Development
Telephone: 973-635-9040
Fax: 973-635-9878
E-Mail: mcarr@advbiomat.com
Website: www.advbiomat.com
