Grifols receives FDA approval to treat surgical bleeding in pediatric patients with its fibrin sealant solution

Barcelona, Spain, Oct. 29, 2024 - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding has received approval from the United States Food and Drug Administration (FDA) for pediatric patients.

The U.S. indication for children and adolescents extends the availability of FS, which is already approved for this patient segment in Europe, in addition to adults. During surgery Grifols FS promotes hemostasis and tissue sealing, resulting in reduced blood loss and potentially fewer complications.

Grifols FS biosurgery treatment is commercialized as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe and elsewhere. Both brands are marketed and distributed by Johnson & Johnson MedTech, as part of a strategic collaboration between the two companies announced in 2019.

Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. The FS solution is now available in 18 countries.

In early 2023, Grifols announced that it had met all primary and secondary endpoints of its phase 3b study evaluating the administration of Grifols FS to pediatric patients, defined as those not having reached 18 years of age. Researchers conducted a global prospective, randomized, active-controlled, single-blind, parallel group clinical trial designed to evaluate the safety and efficacy of the FS as an adjunct to hemostasis during surgery in pediatric patients (compared with an active control). The study included a total of 178 patients enrolled and treated across 18 recruitment centers.

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

“Developing innovative biosurgery solutions reflects Grifols’ ability to provide patients with more medicines across many therapeutic areas to enhance their well-being,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer.

It’s estimated that between roughly one-third and two-thirds of open surgeries experience disruptive bleeding,¹ while challenging and uncontrollable bleeding during surgery is associated with high mortality rates.^1,2

About VISTASEAL

VISTASEAL is a single-use product that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue.

VISTASEAL™ Fibrin Sealant (Human)
IMPORTANT SAFETY INFORMATION

INDICATION

VISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding 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.

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

The most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.