Ethicon, part of Johnson & Johnson Medical Devices Companies, has launched VISTASEAL Fibrin Sealant (Human) to help surgeons to control bleeding during surgical operations.
The sealant features a combination of clotting proteins found in human plasma, fibrinogen and thrombin. It forms a quick, adherent and durable clot upon application of the sealant to the bleed.
According to Ethicon, the sealant has shown to stop bleeding even in high-risk patients.
During three randomised controlled studies, VISTASEAL was associated with a lower overall haemostatic retreatment rate of 0.9%-7.8% against standard treatments of 8.0%-16.7%.
Henry Ford Hospital director of surgical oncology David Kwon said: “Surgical patients often present with multiple risk factors such as coagulopathies, uncontrolled diabetes, renal or liver failure or are taking anticoagulants or chronic antiplatelet therapies that may interfere with the body’s natural ability to form a clot, which increases the risk of surgical bleeding.
“VISTASEAL has the potential to offer a rapid, adherent, durable clot even in my most demanding cases.”
VISTASEAL Fibrin Sealant (Human) is the first innovation following Ethicon’s strategic partnership with blood plasma-based products provider Grifols, which developed the sealant and licensed it to Ethicon.
The partnership combines Ethicon’s ability to develop device technology with Grifols’ expertise in producing critical plasma-based therapies.
Claimed to be the first fibrin sealant designed only for spraying without gas in both open and minimally invasive procedures, VISTASEAL comes in pre-filled syringes.
The process reduces some of the steps needed for a set-up with gas and may even cut downtime in the surgical rooms.
Disruptive bleeding events are experienced in 32% to 68% of open surgery cases.
The sealant is for use as an adjunct to haemostasis for mild to moderate bleeding in adults undergoing surgical operations when bleeding cannot be managed by conventional surgical techniques such as suture, ligature and cautery.
VISTASEAL is also considered to be effective in patients treated with heparin, blood thinner.