First cooperation result! Johnson &Grifols hemostatic protein spray won FDA 510 (k) license
Last Update: 2020-06-19
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In June 19th, the Johnson Ethicon Department announced that its Vistaseal haemostatic protein spray has been licensed by the US FDA 510 (k) to prevent moderate bleeding during laparotomy or laparoscopic surgery< br / > vistaseal airless spraying product is the first result of the cooperation between Johnson & Johnson and Grifols, a plasma derived drug manufacturerGrifols has developed a human fibrin sealant for use in vistaseal where standard bleeding control techniques (sutures, etc.) cannot achieve hemostasisThe Vistaseal hemostasis protein spray can provide two biological components at the same timeAccording to Grifols, the sealant is made from coagulin fibrinogen and thrombin< br / > the product is expected to be available in the second half of this year and will be sold in the name of veraseal in markets outside the US< br / > along with the cooperation, Johnson & Johnson and Grifols also plan to develop other devices, such as those used to assist in thrombus surgery, including pairing lyophilized thrombin with Ethicon's surgiflo hemostatic matrix, which can provide a solution for platelet adhesion and fibrin clot formation< br / > Grifols has also previously signed a cooperation agreement with Johnson & Johnson to provide Ethicon with its thrombin products for research, development and exploration of a series of existing products in the next few yearsJohnson & Johnson Ethicon's biosurgery portfolio also includes the Surgicel family of absorbable hemostatics, such as powders used to control the continuous bleeding of blood on open wounds, and the evicel fibrin sealant for high-risk patients< br / > Johnson said that in the current 1 / 3-2 / 3 open surgical procedures, there will be destructive bleeding events, and may cause harmful complications due to fluid and air leakageWith more patients with complications and other factors such as the increased risk of surgical bleeding caused by aging population, the incidence of devastating bleeding events or serious complications will continue to rise, and the future market prospects are very promising< br / > reference source: FDA clears J & J and Grifols' blood stopping protein spring for critical blends
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