Grifols' VISTASEAL Receives FDA Approval for Pediatric Surgical Bleeding
核心洞察
Grifols' fibrin sealant (FS), VISTASEAL, gains FDA approval for controlling surgical bleeding in pediatric patients, expanding its availability in the U.S.
The approval is based on a Phase 3b study demonstrating over 95% efficacy in achieving hemostasis within four minutes in pediatric patients.
VISTASEAL combines human fibrinogen and thrombin, applied using Johnson & Johnson MedTech's airless spray technology to rapidly form clots.
Grifols has received FDA approval for its plasma-derived fibrin sealant (FS), VISTASEAL, to control surgical bleeding in pediatric patients. This approval extends the availability of VISTASEAL, already approved for adults and pediatric patients in Europe, to children and adolescents in the U.S.
Clinical Efficacy and Safety
The FDA's decision was supported by a Phase 3b study in which VISTASEAL demonstrated a greater than 95% efficacy rate in achieving hemostasis within four minutes of application. The global, prospective, randomized, active-controlled, single-blind, parallel-group clinical trial included 178 patients across 18 recruitment centers. The safety profile was also favorable, with a comparable distribution of adverse events between treatment arms.
Mechanism of Action
VISTASEAL combines two human plasma proteins, fibrinogen and thrombin, to promote hemostasis and tissue sealing during surgery. It is applied using Johnson & Johnson MedTech’s airless spray technology, facilitating rapid clot formation. This FS solution is now available in 18 countries.
Addressing Surgical Bleeding
Surgical bleeding poses a significant challenge, with estimates suggesting that one-third to two-thirds of open surgeries experience disruptive bleeding. Uncontrollable bleeding during surgery is associated with high mortality rates, underscoring the need for effective hemostatic agents like VISTASEAL.
VISTASEAL: Fibrin Sealant (Human)
VISTASEAL is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
Important Safety Information
Contraindications: Do not inject directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding. Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products. Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
Warnings and Precautions: Thromboembolic events may occur if VISTASEAL™ is administered intravascularly. Hypersensitivity reactions can occur. May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions: The most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea.