The sealant system is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard techniques (suture, ligature, cautery) are ineffective or impractical.
Vistaseal fibrin sealant consists of a combination of fibrinogen and thrombin, which are clotting proteins found in human plasma. It is designed to form a rapid, adherent and durable clot and sustain hemostasis, even in high-risk patients, when applied to the bleeding site.
Ethicon said Vistaseal, which comes in pre-filled syringes, is the first fibrin sealant exclusively designed to be sprayed without gas in open and minimally invasive procedures, eliminating steps required for set-up and potentially saving valuable time in the operating room.
In three randomized controlled trials, the sealant was associated with a lower overall hemostatic retreatment rate (0.9% to 7.8%) when compared to standard treatments (8% to 16.7%), according to a news release.
Vistaseal is the first product to come out of a strategic partnership between Ethicon and Grifols (NSDQ:GRFS), which developed the sealant and licensed it to Ethicon. In June, Ethicon won FDA clearance for its airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding.
“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,” Henry Ford Hospital director of surgical oncology Dr. David Kwon said in the release. “Vistaseal has the potential to offer a rapid, adherent, durable clot even in my most demanding cases.”
“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,” added Ethicon president of global biosurgery Oray Boston. “We will continuously aim to advance the standard of care in surgery to better serve health care professionals and improve outcomes for patients.”