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Grifols Receives FDA Approval To Treat Surgical Bleeding In Pediatric Patients With Its Fibrin Sealant Solution

Benzinga ·  Oct 29 20:09
  • Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis
  • Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients

BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- 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.

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