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 Baxters 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 Baxters 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.
Ive spent my entire career involved with surgery in various capacities, and Ive 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 teams 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configuration of choice because of its simple and easy preparation.4 In this latest design, the diluent ampoule has been replaced by pre-filling the existing mixing syringe so that Floseal can be prepared more quickly than the current configuration.
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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. Baxters 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 Baxters portfolio, please visit https://advancedsurgery.baxter.com/.
About Baxters 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.
Every day, millions of patients and caregivers rely on Baxters leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, weve 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, Baxters employees worldwide are now building upon the companys 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.
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
Jessica Szramiak, (224) 948-5353
Clare Trachtman, (224) 948-3085