The FDA has granted approval to VISTASEAL, a plasma-protein-based fibrin sealant (FS) developed by Grifols, for use in controlling surgical bleeding in pediatric patients. This approval expands the availability of VISTASEAL, already marketed in the United States by Johnson & Johnson, to a younger population, offering a new option for managing bleeding during surgical procedures.
VISTASEAL works by combining fibrinogen and thrombin proteins, which, when applied using Johnson & Johnson MedTech's airless spray technology, rapidly form clots to achieve hemostasis and seal tissues. According to Grifols, this can lead to reduced blood loss and potentially fewer complications during surgery. The sealant is indicated for use when standard surgical techniques like suture or cautery are insufficient to control mild-to-moderate bleeding.
The approval was supported by data from a Phase 3b study that evaluated the safety and efficacy of VISTASEAL in pediatric patients (defined as those under 18 years of age). The global, prospective, randomized, active-controlled, single-blind, and parallel-group clinical trial enrolled 178 patients across 18 recruitment centers. The study's primary and secondary outcomes were met, with both treatment arms achieving a greater than 95% efficacy rate, defined as hemostasis within 4 minutes of application. Grifols reported that the safety and tolerability profile of VISTASEAL was favorable, with a comparable distribution of adverse events between the treatment arms.
While VISTASEAL offers a valuable tool for surgeons, it is contraindicated for direct injection into the circulatory system, use in cases of severe arterial bleeding, and in patients with a history of anaphylaxis or severe systemic reactions to human blood products. The most common adverse reactions reported in more than 1% of patients were procedural pain and nausea. Other warnings include the risk of thromboembolic events if administered intravascularly, potential hypersensitivity reactions, and a risk of transmitting infectious agents.
With this FDA approval, VISTASEAL is now available in 18 countries, providing a significant advancement in the management of surgical bleeding in pediatric patients.
