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Ready-to-use synthetic bone graft substitute designed for ease of
use and fast application
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Enhances growing osteobiologics portfolio in Baxter’s Advanced
Surgery business
DEERFIELD, Ill.--(BUSINESS WIRE)--
Baxter International Inc. (NYSE:BAX), a global leader in advancing
surgical innovation, today announced U.S. Food and Drug Administration
(FDA) clearance of Actifuse Flow Bone Graft Substitute for use in
a variety of orthopedic surgical procedures. As the newest addition to
Baxter’s growing osteobiologics surgery portfolio, Actifuse Flow
offers accelerated bone growth in a new, easy-to-use, prepackaged
delivery syringe for precise placement into small bony voids or gaps in
the skeletal system.
Actifuse Flow utilizes the proprietary silicate-substituted
technology of Baxter’s Actifuse Bone Graft Substitute, which
enhances silicon levels to accelerate bone formation1. Actifuse
Flow comes ready to use with no mixing or preparation involved and
maintains its flowable consistency throughout surgery. The bone graft
substitute is delivered directly from a pre-loaded syringe with the
ability to start and stop delivery, making it compatible with open and
less invasive surgical techniques and well-suited for filling small bone
defects and complex geometries. As the graft substitute resorbs, it is
replaced by the patient’s own bone during the body’s healing process.
Baxter expects Actifuse Flow to be used in a variety of
orthopedic surgeries in the pelvis, extremities, and posterolateral
spine.
“Baxter’s Actifuse Bone Graft Substitute has been demonstrated in
preclinical models to show greater new normalized bone volumes over
other available bone graft substitutes. As the graft resorbs into the
body, it is replaced by natural bone during the healing process. Actifuse
Flow offers that same reliability in an easy-to-use delivery device.
I am pleased to count on the science behind Actifuse Flow to
accelerate bone formation in my patients,” said Robert Norton, MD, an
orthopedic spine surgeon serving patients in Boca Raton, Florida.
“As part of our growing product portfolio, Actifuse Flow builds
on the extensive clinical experience of our Actifuse Bone Graft
Substitute,” said Wil Boren, president of Baxter’s Advanced Surgery
business. “We strive to pioneer products that provide surgeons
innovative and dependable tools to help enhance healing, improve
outcomes and reduce the total cost of care.”
Actifuse Flow is the latest addition to Baxter’s osteobiologics
surgery portfolio, which also includes Actifuse ABX, Actifuse
Shape, Actifuse MIS and Altapore. These products are
based on a proprietary silicate-substituted technology designed to
accelerate bone growth and come in varying configurations to accommodate
different surgical needs. Baxter expects Actifuse Flow to be
available to U.S. customers by year-end. It will be sold in three
convenient sizes: 5 mL, 3 mL and 1.5 mL.
About Baxter
Every day, millions of patients and caregivers rely on Baxter’s leading
portfolio of critical care, nutrition, renal, hospital and surgical
products. For more than 85 years, we’ve been operating at the critical
intersection where innovations that save and sustain lives meet the
healthcare providers that make it happen. With products, technologies
and therapies available in more than 100 countries, Baxter’s employees
worldwide are now building upon the company’s rich heritage of medical
breakthroughs to advance the next generation of transformative
healthcare innovations. To learn more, visit www.baxter.com and
follow us on Twitter, LinkedIn and Facebook.
Actifuse Flow Bone Graft Substitute Indication
Actifuse Flow is a bone void filler intended only for orthopedic
applications as a filler for gaps and voids that are not intrinsic to
the stability of the bone structure. Actifuse Flow is indicated
to be packed gently into bony voids or gaps of the skeletal system,
i.e., extremities, pelvis, and spine, including use in posterolateral
spinal fusion procedures with appropriate stabilizing hardware. These
defects may be surgically created osseous defects or osseous defects
created from traumatic injury to the bone. The product provides a bone
void filler that resorbs and is replaced by bone during the healing
process.
Important Risk Information for Actifuse Flow Bone Graft Substitute
Actifuse Flow is contraindicated where the device is intended as
structural/load-bearing support in the skeleton system. Actifuse Flow bone
graft substitute has not been cleared for vertebroplasty.
Attempts should not be made to modify the size of the granules or to
change their shape. It is important to maximize contact between existing
bone and the implant to ensure proper bone regeneration.
The effect of mixing Actifuse Flow with substances other than
sterile saline/water, autologous blood or bone marrow aspirate is
unknown.
Rx Only.For safe and proper use of this device, refer to
the full Instructions for Use.
This release includes forward-looking statements concerning Actifuse
Flow, including potential benefits associated with its use [and
anticipated launch dates]. The statements are based on assumptions about
many important factors, including the following, which could cause
actual results to differ materially from those in the forward-looking
statements: satisfaction of regulatory and other requirements; actions
of regulatory bodies and other governmental authorities; product
quality, manufacturing or supply, or patient safety issues; changes in
law and regulations; and other risks identified in Baxter's most recent
filing on Form 10-K and other SEC filings, all of which are available on
Baxter's website. Baxter does not undertake to update its
forward-looking statements.
Baxter, Actifuse Flow, Actifuse ABX, Actifuse Shape, Actifuse MIS and
Altapore are registered trademarks of Baxter International Inc.
1 Hing KA, et al. Comparative performance of three ceramic
bone graft substitutes. Spine J. 2007; 7(4):475-490.
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Baxter International Inc.
Media Contact
Bess Featherstone,
(224) 948-5353
media@baxter.com
or
Investor
Contact
Clare Trachtman, (224) 948-3085
Source: Baxter International Inc.