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Design enhancements allow for faster preparation of Floseal
with same trusted safety and efficacy
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Reinforces Baxter’s efforts to develop products that support
operating room nurses and surgeons
NASHVILLE, Tenn.--(BUSINESS WIRE)--
Baxter International Inc. (NYSE:BAX), a global leader in advancing
surgical innovation, today announced that it has received U.S. Food and
Drug Administration (FDA) approval for faster preparation of its leading
hemostatic product, Floseal Hemostatic Matrix, at the 2019
Association of periOperative Registered Nurses (AORN) Global Surgical
Conference and Expo. This next generation of Floseal has 20
percent fewer components and steps to prepare,1 making it
easier and faster for operating room (OR) nurses to get Floseal
in the hands of surgeons to help stop bleeding during procedures. The
new design will be on display at Baxter’s AORN booth #1624.
“We are focused on advancing the art of healing in the operating room
with our innovative and dependable surgical products that address
intraoperative bleeding,” said Wil Boren, president of Baxter’s Advanced
Surgery business. “When creating the next generation of Floseal,
we had OR nurses in mind. We listened to their feedback so that we could
deliver on our promise of customer-inspired innovation.”
With 20 years of leadership in hemostasis and as a frequently chosen
advanced hemostatic agent,2Floseal has been proven to
perform quickly and consistently across a range of bleeds in surgical
procedures.3 A 13cm Malleable Applicator is included with
every Floseal kit and allows surgeons to maneuver the product
into the proper position.
“I’ve spent my entire career involved with surgery in various
capacities, and I’ve seen firsthand the importance that speed and
precision play when it comes to preventing bleeding complications for
patients,” said Mary Anne Sanford, BSN, RN, CNOR and senior manager,
Global Medical Affairs at Baxter. “The latest design enhancements to Floseal
make it easier and faster to prepare, enhancing the ability of
perioperative nurses to focus their efforts to coordinate and support
the surgical team’s activities throughout a procedure.”
Floseal has been ranked by registered nurses in ORs across the
U.S. as the flowable configuration of choice because of its simple and
easy preparation.4 In this latest design, the diluent ampoule
has been replaced by pre-filling the existing mixing syringe so that Floseal
can be prepared more quickly than the current configuration.
Both active and passive adjunctive hemostatic agents are available to
help control bleeding in surgical procedures when ligature or
conventional methods are ineffective or impractical. Baxter’s broad
portfolio of hemostatic and sealing agents effectively work to stop
bleeding in a variety of anatomies to help lower bleeding-related
complications and to reduce overall costs. To learn more about Floseal
and the rest of Baxter’s portfolio, please visit https://advancedsurgery.baxter.com/.
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 to 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.
Rx Only.For safe and proper use of this device, refer to
the full Instructions for Use.
About Floseal
Important Safety Information
Floseal Matrix is indicated in surgical procedures (other than
ophthalmic) as an adjunct to hemostasis when control of bleeding by
ligature or convention procedure is ineffective or impractical.
Important Risk Information for Floseal Matrix
Do not inject or compress Floseal Matrix into blood vessels. Do
not apply Floseal Matrix in the absence of active blood flow,
e.g., while the vessel is clamped or bypassed, as extensive
intravascular clotting and even death may result.
Do not use Floseal Matrix in patients with known allergies to
materials of bovine origin. Do not use Floseal Matrix in the
closure of skin incisions because it may interfere with the healing of
the skin edges.
Floseal Matrix contains Thrombin made from human plasma. It may
carry a risk of transmitting infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Floseal Matrix is not intended as a substitute for meticulous
surgical technique and the proper application of ligatures or other
conventional procedures for hemostasis.
Excess Floseal Matrix (material not incorporated in the
hemostatic clot) should always be removed by gentle irrigation from the
site of application. Floseal Matrix swells by approximately 10%
to 20% after product is applied. Maximum swell volume is achieved within
about 10 minutes.
The safety and effectiveness of Floseal Matrix has not been
established in children under 2 years of age and pregnant women.
Do not use air to remove residual Floseal Matrix from Applicator
tip. The Applicator tips should not be cut. Do not use Floseal
Matrix on bone surfaces where adhesives, such as methylmethacrylate or
other acrylic adhesives, will be required to attach a prosthetic device.
This release includes forward-looking statements concerning Floseal,
including potential benefits associated with its use. 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 and Floseal are registered trademarks of Baxter
International Inc.
1 Floseal Hemostatic Matrix Instructions for Use. Hayward,
CA: Baxter Healthcare Corporation.
2 2017 total unit
sales (DRG data)
3 D. Makhija, M. Rock, Y. Xiong, J. D.
Epstein, M. R. Arnold, O. M. Lattouf & D. Calcaterra (2017)
Cost-consequence analysis of different active flowable hemostatic
matrices in cardiac surgical procedures, Journal of Medical Economics,
20:6, 565-573, DOI:10.1080/13696998.2017.1284079
4 Data
on file – Time Motion Study - Study Number: BXU528129
View source version on businesswire.com:
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Media Contact
Jessica Szramiak, (224) 948-5353
media@baxter.com
Investor
Contact
Clare Trachtman, (224) 948-3085
Source: Baxter International Inc.