November 6, 2025 (DEERFIELD, Ill.) – Baxter International Inc. has received clearance under the Medical Device Regulation for its Floseal Hemostatic Matrix device, an advanced adjunct hemostatic agent designed to help control bleeding in a wide range of surgical scenarios. The approval allows healthcare professionals to utilize Floseal to improve patient safety and surgical outcomes by providing reliable and effective bleeding management.
“Effective bleeding control remains a critical concern in surgery, and Floseal offers clinicians a proven solution to enhance patient care,” said Shani Alexander, reporting for BioWorld.
Floseal’s formulation combines a gelatin matrix with thrombin, allowing it to quickly adhere to bleeding sites, promote clot formation, and reduce the risk of excessive blood loss. The device has been used extensively in hospitals globally and is now formally cleared under the latest regulatory standards in the European market.
Key Points:
- Device: Floseal Hemostatic Matrix, an adjunct hemostatic agent
- Purpose: Controls bleeding during surgery, enhancing patient safety and outcomes
- Mechanism: Combines gelatin matrix with thrombin to promote rapid clotting
- Regulatory Status: Cleared under Medical Device Regulation in Europe
- Clinical Impact: Provides surgeons with a reliable tool for managing diverse bleeding scenarios
- Global Use: Previously utilized worldwide; formal European clearance reinforces adoption in clinical practice
