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Specially designed to enhance and accelerate bone growth with
proprietary silicate-substituted technology and optimized micro and
macro porosity
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Features precise handling characteristics
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Can now be used in posterolateral spinal fusion procedures when
combined with autograft or autogenous bone marrow aspirate, as well as
standalone bone graft substitute to fill bony voids or gaps in
orthopedic applications
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 ALTAPORE Bioactive Bone Graft, a
next-generation bioactive and osteoconductive bone graft substitute, for
use as an autograft extender in posterolateral spinal fusion. ALTAPORE
had previously been cleared for use in orthopedic surgical procedures in
the extremities and pelvis.
ALTAPORE is designed to enhance bone growth with optimized
porosity that promotes earlier vascularization, which plays a central
role in the bone formation process by providing oxygen, nutrients, and
growth factors critical for bone development. ALTAPORE’s porosity
also increases cellular activity by providing more surface area for
cells to travel along the surface of the graft, which promotes new bone
formation. Additionally, ALTAPORE’s unique chemistry contains 0.8
percent silicon by weight, which was shown to be optimal for bone
formation in preclinical studies.
“ALTAPORE utilizes Baxter’s proprietary silicate-substituted
technology and has an enhanced porosity that provides for earlier
vascularization, increased cellular activity and improved volume of new
bone growth. I’ve had a good experience with ACTIFUSE bone graft
substitute, and am looking forward to taking advantage of the novel
characteristics of ALTAPORE for my patients,” said Roger Härtl,
M.D., professor of Neurological Surgery, director of Spinal Surgery, and
director of the Weill Cornell Medicine Center for Comprehensive Spine
Care in New York.
ALTAPORE has been formulated to meet surgeons’ needs, as it is
easy to store, handle and implant. Its precise handling characteristics
allow the putty to be molded into multiple shapes to adapt to various
surgical needs. Additionally, in a pre-clinical posterolateral spinal
fusion model, ALTAPORE used as an autograft extender exhibited
similar fusion rates to iliac crest autograft, which is considered the
current standard of care in spine surgical techniques. The iliac crest
is an area of the pelvis commonly used for acquiring autogenous bone
graft.
“Providing surgeons with versatile tools like ALTAPORE is
critical to our commitment to partner with clinicians to advance healing
in the operating room,” said Wil Boren, president of Baxter’s Advanced
Surgery business. “With this clearance, more surgeons will have access
to this innovative bone graft substitute as we look to improve outcomes
across our entire portfolio of surgical products.”
ALTAPORE Bioactive Bone Graft is the latest addition to Baxter’s
growing osteobiologics portfolio of surgical products, which includes Actifuse
Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow.
Baxter received 510(k) clearance for the use of ALTAPORE as an
autograft extender in posterolateral spine in August 2018. The company
has started the process of packaging inventories carrying the new
FDA-approved labeling and expects to start selling product in the United
States by year-end. Baxter intends to unveil ALTAPORE at the 2018
North American Spine Society annual congress Sept. 26-29 in Los Angeles.
About Baxter’s Surgery Portfolio
Baxter is committed to partnering with clinicians to make a meaningful
impact on patient care in operating rooms (OR) in nearly 60 countries.
Surgeons rely on our hemostats to stop bleeding during surgery, our
sealants to close wounds, and our repair patches and biologics to
promote healing. We are focused on pioneering innovative and dependable
surgical tools and programs that help improve clinical outcomes while
reducing the total cost of care.
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.
Indications for Use for ALTAPORE Bioactive Bone Graft
ALTAPORE is an implant intended to fill bony voids or gaps of the
skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE
may be used with autograft as a bone graft extender or bone marrow
aspirate in extremities and pelvis. ALTAPORE must be used in
combination with autograft as a bone graft extender or autogenous bone
marrow aspirate in posterolateral spinal fusion procedures. These
osseous defects are surgically created or the result of traumatic injury
to the bone and are not intrinsic to the stability of the bony
structure. ALTAPORE resorbs and is replaced with bone during the
healing process.
Important Risk Information
ALTAPORE is contraindicated where the device is intended as
structural support in the skeletal system. ALTAPORE has not been
cleared for use in vertebroplasty. Attempts should not be made to modify
the size of the granules or to changetheir shape. It is
important to maximize contact between existing bone and the implant to
ensure proper bone regeneration.The effect of mixing ALTAPORE
with substances other than bone marrow aspirate or autologous bone 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 ALTAPORE,
including potential benefits associated with its use and its anticipated
market launch date. 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, ALTAPORE, Actifuse Shape, Actifuse MIS, Actifuse
ABX and Actifuse Flow are registered trademarks of Baxter
International Inc.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180926005507/en/
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.