|New Data Indicates Use of Baxter’s FLOSEAL in Cardiac and Spinal Surgeries May Be Associated with Lower Hospital Costs|
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Complications during surgery, such as the need for blood transfusions or
longer times in the operating room, can increase costs for a hospital
and impact patient care. In the cardiac
surgery analysis, researchers calculated the potential cost savings
of using FLOSEAL when compared to SURGIFLO® to be
“Based on the real-world outcomes observed in the earlier study, this
new health economics analysis identifies a substantial opportunity for
hospitals to realize potential cost savings on cardiac surgery
operations, which are among the surgical specialties the most
susceptible to the occurrence of intra-operative and post-operative
In the second
study, researchers identified potential cost savings of
In addition to reducing a hospital’s costs, addressing bleeding effectively and quickly is critical to avoiding major and minor complications for patients. As a leader in hemostasis, Baxter is committed to providing innovative solutions for surgeons. Conventional methods of controlling bleeding, such as suture, cautery or ligature, may be ineffective or impractical in certain surgery settings. In these cases, surgeons may use hemostatic agents such as glues, adhesives and sealants to help address bleeding. FLOSEAL is an indicated and approved adjunct hemostatic agent proven effective in a wide-range of bleeding scenarios.6
About the Studies
The new economic analyses quantify the potential cost savings to
hospitals associated with FLOSEAL use, assuming the real-world outcomes
observed in earlier studies are attributable to FLOSEAL use. Both
economic analyses are based on previously published retrospective
analyses which observed certain improved outcomes associated with
surgical cases in which FLOSEAL rather than SURGIFLO® was used. By
nature of their design, these retrospective studies could not
conclusively determine whether FLOSEAL use was causally related to the
observed improved clinical outcomes. The studies include assessments of
a large number of cases with data extracted from Premier’s
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
FLOSEAL Hemostatic Matrix Indication
FLOSEAL Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional 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.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
This release includes forward-looking statements concerning FLOSEAL,
including anticipated 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: the applicability of the
studies to related cost savings estimates (as described above in “About
the Studies”); 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
1 Makhija, D., et al. Cost-consequence analysis of
different active flowable hemostatic matrices in cardiac surgical
procedures. J Med Econ. 2017 Feb 3:1-9. doi:
10.1080/13696998.2017.1284079. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28097913
Baxter and FLOSEAL are registered trademarks of
SURGIFLO® is a registered trademark of
Baxter International Inc.