FDA Approves Grifols' Fibrin Sealant for Pediatric Surgical Bleeding

In Barcelona, Spain, on October 29, 2024, Grifols, a global healthcare company specializing in plasma-derived medicines, announced that their fibrin sealant (FS) product has been approved by the United States Food and Drug Administration (FDA) for use in pediatric patients. This approval expands the FS's availability, which was previously limited to adult patients in the U.S. and pediatric patients in Europe.

Grifols FS is a plasma-protein based treatment designed to promote hemostasis and tissue sealing during surgery, thereby reducing blood loss and potential complications. It is marketed as VISTASEAL™ in the U.S. and Canada, and as VERASEAL™ in Europe and other regions, through a strategic partnership with Johnson & Johnson MedTech that began in 2019. This innovative solution combines fibrinogen and thrombin, and it is applied using Johnson & Johnson MedTech’s airless spray technology to quickly form clots and control bleeding.

In early 2023, Grifols completed a phase 3b study that successfully met its primary and secondary endpoints, demonstrating the efficacy and safety of FS in pediatric patients. The study, which was a global prospective, randomized, active-controlled, single-blind, parallel group clinical trial, included 178 patients from 18 different recruitment centers. It aimed to evaluate FS as an adjunct to hemostasis during surgery in patients under 18 years old. The results showed a greater than 95% efficacy rate in both treatment arms, with hemostasis achieved within four minutes of application. Additionally, the safety and tolerability profile of FS was favorable, as adverse events were similarly distributed between both arms of the study.

Joerg Schuettrumpf, Grifols' Chief Scientific Innovation Officer, emphasized the company's commitment to developing innovative biosurgery solutions to enhance patient well-being across various therapeutic areas.

Surgical bleeding remains a significant challenge, with estimates suggesting that between one-third to two-thirds of open surgeries encounter disruptive bleeding. Uncontrollable bleeding during surgery is associated with high mortality rates.

VISTASEAL™ is a single-use product that combines human fibrinogen and human thrombin to aid in controlling mild to moderate bleeding when conventional surgical techniques, such as suturing or cautery, are ineffective. This sealant is applied in a thin layer over bleeding tissue to create a cross-linked fibrin clot, achieving hemostasis. It is particularly useful in high-risk patients with concerns about coagulopathy, antiplatelet, anticoagulant usage, and friable tissue.

VISTASEAL™ Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding during surgery when standard surgical techniques are ineffective or impractical. It can be used in patients who have been heparinized.

However, VISTASEAL™ should not be injected directly into the circulatory system or used for severe arterial bleeding. It should not be used in patients with a history of severe reactions to human blood products. Moreover, the minimum recommended distance between the applicator tip and the bleeding site must be maintained during application to avoid complications.

Possible adverse reactions include procedural pain and nausea, reported in over 1% of patients. There is also a risk of thromboembolic events, hypersensitivity reactions, and the potential transmission of infectious agents.

Grifols continues to innovate and expand its offerings in the healthcare sector, providing essential plasma-derived medicines and other biopharmaceuticals to meet the needs of patients with chronic, rare, and life-threatening conditions. The company operates over 390 donation centers worldwide and is recognized as a leader in transfusion medicine, offering comprehensive solutions to enhance safety from donation to transfusion.

With more than 23,000 employees across 30 countries, Grifols is dedicated to maintaining a sustainable business model that prioritizes continuous innovation, quality, safety, and ethical leadership, further solidifying its position as a leader in the global healthcare industry.