Grifols' Fibrin Sealant Gains FDA Approval for Pediatric Surgical Bleeding
Key Insights
Grifols' fibrin sealant (FS) has been approved by the FDA for use in pediatric patients undergoing surgery to control bleeding (search), expanding its availability in the U.S.
The approval is based on a Phase 3b study demonstrating the safety and efficacy of Grifols FS in achieving hemostasis within four minutes in pediatric surgical patients.
VISTASEAL™/VERASEAL™, Grifols' FS biosurgery treatment, combines fibrinogen and thrombin to promote clot formation and reduce blood loss during surgical procedures.
Grifols, a global healthcare company specializing in plasma-derived medicines, has received FDA approval for its fibrin sealant (FS) to control surgical bleeding (search) in pediatric patients. This approval extends the availability of FS, already approved for adults and in Europe for pediatric use, to children and adolescents in the United States.
The FDA's decision was supported by data from a Phase 3b clinical trial. The global prospective, randomized, active-controlled, single-blind, parallel-group study evaluated the safety and efficacy of Grifols FS as an adjunct to hemostasis during surgery in pediatric patients compared to an active control. The trial included 178 patients across 18 recruitment centers.
Phase 3b Trial Results
The Phase 3b study achieved a greater than 95% efficacy rate in both treatment arms, with hemostasis achieved within four minutes of application. The study also demonstrated a good safety and tolerability profile for Grifols FS, with a comparable distribution of adverse events between the treatment arms.
Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer, stated, "Developing innovative biosurgery solutions reflects Grifols’ ability to provide patients with more medicines across many therapeutic areas to enhance their well-being."
VISTASEAL™/VERASEAL™
Grifols FS is commercialized as VISTASEAL™ in the U.S. and Canada, and as VERASEAL™ in Europe and other regions. These brands are marketed and distributed by Johnson & Johnson MedTech (search) as part of a strategic collaboration established in 2019.
The FS solution combines two plasma proteins, fibrinogen and thrombin, and is applied using Johnson & Johnson MedTech (search)’s airless spray technology to facilitate rapid clot formation. It is now available in 18 countries.
Addressing Surgical Bleeding
It is estimated that between one-third and two-thirds of open surgeries experience disruptive bleeding (search). Challenging and uncontrollable bleeding during surgery is associated with high mortality rates.
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding (search) 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.