Sealant launched for bleed management during surgery

Ethicon, a Johnson & Johnson company, has launched Vistaseal Fibrin Sealant to help surgeons manage bleeding during surgery.

It contains a contains a combination of fibrinogen and thrombin, clotting proteins found in human plasma. When applied to the bleeding site, it forms a rapid, adherent, and durable clot and has been demonstrated to sustain haemostasis (stoppage of bleeding), even in high-risk patients. In three randomised controlled trials, Vistaseal was associated with a lower overall haemostatic retreatment rate (0.9%-7.8%) compared to standard treatments (8.0%-16.7%).

David Kwon, director of surgical oncology at Henry Ford Hospital, 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 is the first innovation to emerge from Ethicon's strategic partnership with Grifols, which developed the Vistaseal Fibrin Sealant (Human) and licensed it to Ethicon. The collaboration combines Ethicon's background in developing device technology with Grifols' production of plasma-based therapies.

Vistaseal is designed to be sprayed without gas in both open and minimally invasive procedures, and it comes in pre-filled syringes. This eliminates some of the steps required for set-up with gas and may save valuable time in the operating room. The Vistaseal Dual Applicator tip is also uniquely malleable enabling access to difficult anatomy and enhanced spray control.

Throughout a surgical procedure, bleeding must be controlled not only to provide a clear view of the operative site, but also to prevent the adverse clinical outcomes associated with blood loss.

Vistaseal is indicated as an adjunct to haemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) are ineffective or impractical. Vistaseal is effective in patients treated with heparin.

Oray Boston, president, global biosurgery, Ethicon, said: "Vistaseal is the latest addition to our broad portfolio of primary and adjunctive haemostat solutions that address the growing and wide-ranging challenges surgeons face in managing bleeding. We will continuously aim to advance the standard of care in surgery to better serve health care professionals and improve outcomes for patients."