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Grifols' Fibrin Sealant VISTASEAL™ Receives FDA Approval for Pediatric Surgical Bleeding

• Grifols' VISTASEAL™ fibrin sealant secures FDA approval for managing surgical bleeding in pediatric patients in the U.S. • A Phase 3b trial demonstrated over 95% efficacy in achieving hemostasis within four minutes of VISTASEAL™ application. • This approval expands VISTASEAL™ availability, already approved in Europe, enhancing surgical outcomes for younger patients. • VISTASEAL™ is distributed through a strategic partnership with Johnson & Johnson MedTech and is available in 18 countries.

Grifols (NASDAQ:GRFS) has announced that its VISTASEAL™ Fibrin Sealant (FS) has received FDA approval for use in pediatric patients in the United States undergoing surgery. This approval extends the availability of VISTASEAL™, a plasma-derived product already approved for adults and pediatric patients in Europe, to a younger patient population in the U.S.
The Fibrin Sealant combines fibrinogen and thrombin to promote hemostasis and tissue sealing during surgical procedures, reducing blood loss and potential complications. It is applied using Johnson & Johnson MedTech’s airless spray technology to rapidly form clots.

Clinical Trial Results

The FDA approval was supported by data from a Phase 3b clinical trial involving 178 pediatric patients across 18 recruitment centers. The study demonstrated a greater than 95% efficacy rate in achieving hemostasis within four minutes of application. The distribution of adverse events was comparable between treatment arms, indicating a good safety and tolerability profile.
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.”

Market and Distribution

VISTASEAL™ is marketed and distributed through a strategic collaboration with Johnson & Johnson MedTech. The FS solution is currently available in 18 countries. In the U.S. and Canada, the product is known as VISTASEAL™, while in Europe and other regions, it is marketed as VERASEAL™.

Addressing Surgical Bleeding

Surgical bleeding is a common challenge, with estimates suggesting that between one-third and two-thirds of open surgeries experience disruptive bleeding. Uncontrollable bleeding during surgery is associated with high mortality rates, underscoring the importance of effective hemostatic agents.

About VISTASEAL™

VISTASEAL™ is a single-use product designed to control mild to moderate bleeding when standard surgical techniques are ineffective or impractical. It is applied in a thin layer over the bleeding tissue to generate a cross-linked fibrin clot, achieving hemostasis. VISTASEAL™ can be used in high-risk patients with concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue.
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Grifols' VISTASEAL Receives FDA Approval for Pediatric Surgical Bleeding

Grifols' fibrin sealant (FS), VISTASEAL, gains FDA approval for controlling surgical bleeding in pediatric patients, expanding its availability in the U.S.
The approval is based on a Phase 3b study demonstrating over 95% efficacy in achieving hemostasis within four minutes in pediatric patients.

FDA Approves VISTASEAL Fibrin Sealant for Pediatric Surgical Bleeding

The FDA has approved VISTASEAL, a fibrin sealant from Grifols, for controlling surgical bleeding in pediatric patients.
VISTASEAL combines fibrinogen and thrombin proteins to promote hemostasis and tissue sealing during surgery, reducing blood loss.

Grifols' Fibrin Sealant Gains FDA Approval for Pediatric Surgical Bleeding

Grifols' fibrin sealant (FS) has been approved by the FDA for use in pediatric patients undergoing surgery to control bleeding, 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.

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Reference News

[1]
Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin ...
stocktitan.net · Oct 29, 2024

Grifols received FDA approval for its Fibrin Sealant (FS) to treat surgical bleeding in pediatric patients in the U.S., ...

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