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Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant Solution
Grifols Receives FDA Approval for Life-Saving Pediatric Fibrin Sealant
Groundbreaking Treatment for Surgical Bleeding in Children
Grifols, a global leader in plasma-derived medicines, has triumphed in securing FDA approval for its revolutionary fibrin sealant solution, GRF XII Fibrin Sealant Kit.
This milestone marks a significant advancement in pediatric healthcare, empowering surgeons to effectively control bleeding during complex and delicate surgeries in young patients.
Benefits for Pediatric Patients
GRF XII Fibrin Sealant Solution offers a range of advantages for pediatric patients:
- Enhanced Bleeding Control: Its hemostatic properties reduce blood loss, allowing surgeons to operate with greater precision and efficiency.
- Faster Wound Healing: Promotes clot formation, accelerating the healing process and minimizing post-operative complications.
- Reduced Transfusion Need: Efficacy in reducing bleeding may lower the need for blood transfusions, minimizing risks associated with donor blood.
Versatile Applications
The fibrin sealant is indicated for diverse surgical procedures, including:
- Cardiac surgeries
- Neurosurgeries
- Orthopedic surgeries
- Thoracic surgeries
Grifols' Commitment to Innovation
“This FDA approval underscores our unwavering commitment to developing innovative solutions that address unmet medical needs,” said Víctor Grífols Roura, President of Grifols. “GRF XII Fibrin Sealant Solution exemplifies our dedication to improving surgical outcomes and enhancing patient care.”
Evidence-Based Efficacy
The approval is supported by compelling clinical data from a multicenter study involving over 100 pediatric patients. The study demonstrated the sealant's effectiveness in reducing blood loss and improving hemostasis during surgeries.
With FDA approval, Grifols will now make GRF XII Fibrin Sealant Solution widely available to hospitals and surgical centers, giving pediatric patients access to this life-saving treatment.
Source: Grifols Press Release