Grifols Vistaseal Gets Expanded Use in Pediatrics

FDA has approved a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in pediatric patients. The product combines two plasma proteins — fibrinogen and thrombin — and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. J&J markets and distributes the product under a strategic collaboration announced in 2019.

The pediatric indication was based on data from a Phase 3 active-controlled study that met all primary and secondary endpoints, according to the company. “A greater than 95% efficacy rate was achieved in both treatment arms, with hemostasis within four minutes of application,” it says, adding that Vistaseal demonstrated a good safety and tolerability profile.

Vistaseal is described as a single-use product that is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis.