News | April 3, 2017

Baxter Unveils Design Enhancements To FLOSEAL And TISSEEL Hemostatic Agents At AORN Meeting

  • New design for preparation of FLOSEAL enhances patient safety and accelerates preparation process with fewer components and steps
  • TISSEEL Snap Lock Applicator provides greater maneuverability and more secure attachment during surgery
  • Hands-on demonstrations of both products available to attendees this week at AORN conference

Baxter International Inc. is committed to advancing surgical innovation and unveiled new designs that enhance the company’s FLOSEAL and TISSEEL hemostatic products at the Association of periOperative Registered Nurses (AORN) Global Surgical Conference and Expo, which is being held April 1-5.

“Baxter is committed to introducing innovative products designed to improve patient safety and ease of use,” said Wil Boren, President of Baxter’s Advanced Surgery business. “We are excited to bring customer-inspired enhancements to our leading hemostat and sealant portfolio that surgeons rely on for safe and effective solutions to address intraoperative bleeding.”

FLOSEAL Full Sterile Preparation (FSP) represents an improved design for the preparation of Baxter’s FLOSEAL Hemostatic Matrix. FLOSEAL FSP, which has the same indications and formulation as FLOSEAL, can quickly be prepared by a single person with fewer steps, all from within the sterile surgical environment, which also further reduces contamination risk. The new design is currently available in Europe where nurses and surgeons cite several advantages, including simplified and shorter preparation process; more control of preparation consistency; and independent preparation within the surgical team.

Results of two health economic analyses recently published in the Journal of Medical Economics support FLOSEAL as a cost-effective tool for controlling bleeding during cardiac and spinal surgeries that may contribute to significant cost savings for hospitals compared to another flowable hemostat.1, 2 The analyses are based on previously published retrospective studies that observed fewer complications in surgeries that used FLOSEAL, including operating time.3, 4, 5

TISSEEL helps to control bleeding in a variety of situations, including in patients using heparin to reduce the risk of blood clots. The improved applicator unveiled at AORN snaps and locks to the syringe for a more secure attachment while providing surgeons greater maneuverability to position the product where it is needed. This should be particularly helpful during laparoscopic surgery, such as bariatric surgery, when a surgeon has a limited range of motion at the surgical site.

Baxter is providing an advanced look at both FLOSEAL FSP and TISSEEL Snap Lock Applicator in the company’s booth (#1129) at AORN, including the ability to interact with the new products in preparation for the upcoming launches. Attendees can also learn more about effective blood management strategies and see hands-on demonstrations of other products in Baxter’s portfolio.

About Baxter
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.

During surgery, addressing bleeding effectively and quickly is critical to avoiding major and minor complications for patients. 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, glues, adhesives and sealants to help address the bleeding. For example, FLOSEAL and TISSEEL are approved adjunct hemostatic agents proven effective in a wide-range of bleeding scenarios.

Important Safety Information
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.

TISSEEL [Fibrin Sealant] Indications
Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.

Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Selected Important Risk Information for TISSEEL
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients.

  • Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
  • Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set.
  • Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding.
  • Hypersensitivity or allergic/anaphylactoid reactions can occur with the use of TISSEEL.

This release includes forward-looking statements concerning FLOSEAL and TISSEEL, including potential benefits associated with their 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.

1Makhija, 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]

2Makhija, D., et al. Cost-Consequence Analysis of Two Different Active Flowable Hemostatic Matrices in Spine Surgery Patients. J Med Econ. 2017 Feb: 8:1-19 [Epub ahead of print]

3Tackett S, Calcaterra D, Magee G, Lattouf OM. Real world outcomes of hemostatic matrices in cardiac surgery. J Cardiothorac Vasc Anesth. 2014;28(6):1558-1565

4 Price JS. Observational evaluation of outcomes and resource utilization from hemostatic matrices in spine surgery. J Med Econ. 2015 Oct;18(10):777-86.

5 Price JS, Tackett S, Patel V. Observational evaluation of outcomes and resource utilization from hemostatic matrices in spine surgery. J Med Econ 2015: 1-10 (Addendum).

Source: Baxter