FDA approves fibrin sealant to control surgical bleeding in pediatric patients

FDA approves fibrin sealant to control surgical bleeding in pediatric patientsLatest revision | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved the plasma-protein-based fibrin sealant (FS) (VISTASEAL; Grifols) to control surgical bleeding in pediatric patients, according to a press release from Grifols.

During surgery, FS, which is marketed as VISTASEAL in the United States and distributed by Johnson & Johnson, promotes hemostasis and tissue sealing, which leads to reduced blood loss and potentially fewer complications, according to the company.

FS combines the fibrinogen and thrombin proteins, and is applied with Johnson & Johnson MedTech's airless spray technology to rapidly form clots. With the FDA decision, FS is now available in 18 countries.

The single-use product can assist with mild-to-moderate bleeding control when standard surgical techniques (suture or cautery) are ineffective. The sealant is applied in a thin layer over bleeding tissue to generate a cross-linked fibrin clot to achieve hemostasis.

Grifols, in 2023, announced all primary and secondary outcomes of a phase 3b study evaluating FS administration to pediatric patients were met. Patients included in the study were defined as "those not having reached 18 years of age," according to Grifols.

Investigators conducted a global prospective, randomized, active-controlled, single-blind, and parallel group clinical trial and sought to evaluate the safety and efficacy of FS as an adjunct to hemostasis during surgery in this population compared to an active control. In all, 178 patients were enrolled and treated from 18 recruitment centers.

In both treatment arms, a more than 95% efficacy rate was achieved, with hemostasis within 4 minutes of application. FS "demonstrated a good safety and tolerability profile, as the distribution of adverse events was comparable between arms," Grifols published in a statement.

Contraindications for FS, per Grifols:

• 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.

Procedural pain and nausea were the most common adverse reactions (reported in >1% of patients) associated with FS. Other warnings and precautions include:

• 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.

Reference:

Grifols receives FDA approval to treat surgical bleeding in pediatric patients with its fibrin sealant solution. Grifols. Press release. October 29, 2024. Accessed October 29, 2024. https://www.globenewswire.com/en/news-release/2024/10/29/2970751/0/en/Grifols-Receives-FDA-Approval-to-Treat-Surgical-Bleeding-in-Pediatric-Patients-With-its-Fibrin-Sealant-Solution.html