New applicator provides surgeons with greater control during ENT surgeries to help foster improved outcomes for patients
Deerfield, Ill. - December 18, 2018
Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the introduction of the Disposable Curved Applicator, which enhances the delivery experience of its Floseal Hemostatic Matrix product line for procedures in the otolaryngology, head and neck surgical specialty (often referred to as ENT).
With an atraumatic design to help minimize tissue damage during use and a 10cm rigid stainless steel cannula, the Disposable Curved Applicator allows for improved access to the bleeding site and controlled delivery of Floseal. ENT procedures most relevant for this new applicator include addressing intraoperative bleeding during skull base surgery, functional endoscopic sinus surgeries, septoplasties (correction of a deviated septum) and for the control of operative and post-operative bleeding (epistaxis) during nasal and sinus surgery.
“Investing in specialty-driven innovation within our leading hemostats and sealants portfolio is our priority as we work to meet surgeons’ needs so that they can help their patients heal,” said Wil Boren, president of Baxter’s Advanced Surgery business. “Floseal is a proven adjunctive hemostatic product that we are confident otolaryngologists will use to effectively manage intraoperative bleeding. Enhancing the Floseal delivery experience with products like the Disposable Curved Applicator is a critical part of our strategy.”
“While skull base surgery is a highly specialized and minimally invasive surgical technique, it’s important to have hemostatic agents like Floseal at the ready in the event intraoperative bleeding occurs,” said Kevin C. Welch, M.D., Northwestern University. “During procedures where bleeding is a possibility, I trust in the efficacy of a product like Floseal to help me stop the bleeding in a controlled and effective manner.”
Regardless of the surgical specialty, addressing intraoperative bleeding effectively and quickly is important in preventing major complications for patients and reducing the total cost of care. Individuals with uncontrolled intraoperative bleeding are up to four times more likely to die from their surgeries, may need more blood transfusions, and are more likely to have an extended hospital stay.1 With more than 180 published clinical studies2 across spine, cardiac and other surgical specialties, Floseal has proved to be an effective adjunctive hemostatic product in helping to address intraoperative bleeding and continues to be the most frequently chosen active hemostatic agent in the U.S.3
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.
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.
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.
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 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 Stokes, Michael & Ye, Xin & Shah, Manan & Mercaldi, Katie & Reynolds, Matthew & Rupnow, Marcia & Hammond, Jeffrey. (2011). Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC health services research. 11. 135. 10.1186/1472-6963-11-135.
2 Brand name search in PubMed (filters: human, as of 12-Apr-2018).
3 2017 total unit sales (DRG data).