DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a leader in solutions to advance surgical innovation, unveiled multiple new additions to its surgical portfolios at the Association of periOperative Registered Nurses (AORN) Global Surgical Conference & Expo 2023, taking place April 1 through April 4, 2023. These innovations include the launch of the new Baxter Patient Warming system, the unveiling of the Helux Pro Connected Surgical Light, and the launch of Floseal + Recothrom flowable hemostat, all of which are on display in Baxter’s AORN booth #2027.
“Baxter takes a holistic approach to help surgical care teams navigate dynamic operating environments, providing a full suite of OR solutions that support critical decisions for patient care,” said Andrew Frye, president, Patient Support Systems/Global Surgical Solutions and Enterprise Connectivity. “We’re eager to demonstrate how our diverse portfolio of products and services can support delivering great outcomes for patients and maximizing operating room workflow efficiency.”
Products featured at AORN 2023 include the commercial launch of a new conductive Baxter Patient Warming system designed to help achieve and maintain patient normothermia (body temperature within standard limits). The system eliminates the need for disposables, as the warming technology is built into the table pad, which can reach temperatures up to 40 degrees Celsius. In addition, reusable conductive warming blankets can reach temperatures of 43 degrees Celsius and provide an increased surface warming area to help quickly warm from above and below. The system is also air-free, which may reduce risks associated with forced air systems1—such as contamination of the surgical site—and operates quietly. This warming solution can also be combined with WaffleGrip, a positioning accessory that helps keep the patient warm and secure in the steep Trendelenburg position, in which a patient is tilted head-down at up to a 45-degree angle. The Baxter Patient Warming system is compatible with its TS7000, TS7000dV and PST 500 surgical tables.
Baxter also revealed a first look at its Helux Pro Connected Surgical Light, a wired lighting and camera solution for the operating room. Helux Pro features deep cavity lighting, auto pattern assist technology, and a feature which helps eliminate unwanted shadows to provide consistent illumination during a surgical procedure. An included 4K camera offers ultra-high definition, reliable image capture. In addition, Helux Pro includes innovative safety features like sterile light controls and a soft exterior bumper to mitigate accidental damage. Helux Pro is expected to launch later this quarter.
Baxter’s Floseal + Recothrom is the first and only active flowable hemostat to use recombinant DNA technology. Floseal represents more than 20 years of leadership in hemostasis and has been proven to perform quickly and consistently across a range of bleeds in surgical procedures.2 Floseal + Recothrom has a thrombin component manufactured using recombinant DNA technology, and therefore contains no human blood components and eliminates reliance on human blood donations. Together in a single product, Floseal + Recothrom has the same simple preparation3 as Floseal + Human Thrombin but is more than 1.5 times faster4 to prepare, which may help improve operating room efficiency. Floseal + Recothrom 5mL is currently available in the U.S. and Floseal + Recothrom 10mL will be coming later this year.
“When it comes to active hemostats in the operating room, effectiveness and speed are of critical importance given increasing patient complexity,” said Steve Wallace, president, Advanced Surgery. “The development and introduction of Floseal + Recothrom is the result of input from operating room nursing teams who prioritize fast time-to-table and ease of preparation – all areas where Floseal + Recothrom brings unique value.”
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 reduce overall costs. To learn more about Floseal + Recothrom and the rest of Baxter’s Advanced Surgery portfolio, visit https://advancedsurgery.baxter.com/.
Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions 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.
This release includes forward-looking statements concerning potential benefits associated with a conductive Baxter Patient Warming system, Helux Pro and Floseal + Recothrom. 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: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); 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 Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
FLOSEAL with RECOTHROM Indications and Important Risk 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 procedures is ineffective or impractical.
Important Risk Information for FLOSEAL Hemostatic 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 administer to patients with a history of hypersensitivity to RECOTHROM thrombin, any components of RECOTHROM, or hamster proteins. Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM thrombin is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.
Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.
Thrombin must be added to the Gelatin Matrix prior to use.
Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.
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.
The particles of FLOSEAL Matrix swell approximately 10-20% upon contact with blood or other fluids creating a tamponade effect. 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.
As with other hemostatic agents, do not apply FLOSEAL Matrix to sites where there is negative peripheral venous pressure (e.g. due to patient positioning), as material may be drawn into the vascular system potentially resulting in life-threatening thromboembolic events.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
Baxter, Helux, Floseal and Recothrom are registered trademarks of Baxter International Inc. or its subsidiaries.
1 Mehta V. Comparison of forced air and conductive heating systems during outpatient orthopedic surgeries. Journal of Anesthesia and Surgery. 2018. https://doi.org/10.15436/2377-1364.18.1771.
2 Makhija D, Rock M, Xiong Y, et al. Cost-consequence analysis of different active flowable hemostatic matrices in cardiac surgical procedures. Journal of Medical Economics. 2017;20(6):565-773. DOI:10:1080/13696998.2017.1284079.
3 Data on file – Time Motion Study – Study Number: BXU528129
4 Baxter. Data on file.