> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Grifols Vistaseal Gets Expanded Use in Pediatrics
- URL: https://www.fdaweb.com/grifols-vistaseal-gets-expanded-use-in-pediatrics/
- Published: 2024-10-29T12:00:00.000Z
- Updated: 2026-09-14T14:45:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158074

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.