FDA clears J&J and Grifols' blood-stopping protein spray for surgical bleeds

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Ethicon’s Vistaseal dual applicators deliver both of the product’s two biological components, clotting proteins fibrinogen and thrombin, developed by Grifols. (Wikimedia Commons)

Johnson & Johnson’s Ethicon unit has received a 510(k) clearance from the FDA for its Vistaseal applicators, which spray a biological sealant to stem moderate bleeding during open or laparoscopic surgical procedures.

The airless spray products are the first fruit of a broad partnership between the devicemaker and plasma-derived medicine manufacturer Grifols, which developed the human fibrin sealant for use when standard bleeding control techniques like suturing are impractical.

Ethicon’s Vistaseal dual applicator delivers both of the product’s two biological components at once. Made of the clotting proteins fibrinogen and thrombin, the sealant is expected to be available in the second half of this year, according to Barcelona-based Grifols, and will be sold as Veraseal in markets outside the U.S.

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The Vistaseal dual spray applicator. (Ethicon)

As the partnership moves forward, J&J and Grifols plan to develop additional adjunctive blood stoppers for surgery—including pairing lyophilized thrombin with Ethicon’s Surgiflo Hemostatic Matrix, which provides a place for platelets to stick and form fibrin clots.

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In addition, Grifols previously inked a deal to exclusively supply Ethicon with its thrombin for use in a range of current products over the next several years. The latter company's biosurgery portfolio includes the Surgicel line of absorbable hemostats, such as a powder to control continuous oozing of blood across broad surfaces, as well as the Evicel Fibrin Sealant for high-risk patients.

J&J estimates that between one- and two-thirds of open surgery procedures experience disruptive bleeding events, with potentially harmful complications from both fluid and air leaks. In addition, the medtech giant expects those numbers to rise as more patients present with comorbidities and other factors that increase the risk of surgical bleeding, due to an aging population.

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