Johnson & Johnson’s Ethicon unit has launched its blood-stopping protein spray, designed to quickly seal off and control excessive bleeding during open surgeries or minimally invasive procedures.
It’s the first product to graduate from the devicemaker’s collaboration with the plasma-focused Spanish multinational, Grifols. The Vistaseal biological sealant combines human fibrinogen and thrombin, two clotting agents found in the bloodstream.
According to Ethicon, it’s the first fibrin sealant designed to be used without a gas propellant. Delivered in a pre-filled syringe, the spray is designed to rapidly adhere and form a clot over the bleed, and has shown clinical success in high-risk patients—such as those with multiple factors including bleeding disorders, diabetes or organ failure, or patients taking blood thinners or antiplatelet therapies.
Across three randomized trials, Vistaseal demonstrated a lower overall hemostatic retreatment rate compared to standard treatments, the company said. Additionally, Ethicon estimates that between one- to two-thirds of open surgeries experience disruptive bleeding events.
"Vistaseal is the latest addition to our broad portfolio of primary and adjunctive hemostat solutions that address the growing and wide-ranging challenges surgeons face in managing bleeding," Ethicon’s global president of biosurgery, Oray Boston, said in a statement. According to Grifols, the device will be sold as Veraseal in markets outside the U.S.
The spray and applicator received a 510(k) clearance from the FDA in June to help control bleeding during procedures where standard surgery techniques—such as suturing, ligature or cauterization—are ineffective or impractical.
J&J’s collaboration with Grifols includes the development of additional plasma-based devices for stopping surgical bleeds, including a combination of Ethicon’s Surgiflo Hemostatic Matrix and Grifols’ freeze-dried thrombin protein. The absorbable Surgiflo porcine gelatin paste aims to provide a place for platelets to stick and form durable blood clots.
Ethicon previously tapped Grifols to exclusively supply the company with thrombin over a range of products across the next several years, including its Surgicel line of absorbable powder hemostats and its Evicel fibrin sealant for high-risk patients.