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Ethicon launches Vistaseal Fibrin Sealant to manage bleeding during surgery

Tue, 12/03/2019 - 16:45
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Vistaseal is first innovation to emerge from Ethicon’s strategic partnership with Grifols, a pioneer in the plasma industry

Ethicon, a Johnson & Johnson Medical Devices company, has launched Vistaseal Fibrin Sealant (Human) to help surgeons manage bleeding during surgery. Vistaseal Fibrin Sealant (Human) 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, even in high-risk patients. In three randomized controlled trials, Vistaseal was associated with a lower overall haemostatic retreatment rate (0.9%-7.8%) compared to standard treatments (8.0%-16.7%).

"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," said Dr David Kwon, Director of Surgical Oncology, Henry Ford Hospital. "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 plasma industry leader Grifols, which developed the Vistaseal Fibrin Sealant (Human) and licensed it to Ethicon. The collaboration combines Ethicon's expertise in developing device technology with Grifols' ability to produce critical plasma-based therapies.

Vistaseal is the first fibrin sealant exclusively 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, the company stated.

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. An estimated 32 to 68 percent of cases in open surgery procedures experience disruptive bleeding events.

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.

"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," said Oray Boston, President, Global Biosurgery, Ethicon. "We will continuously aim to advance the standard of care in surgery to better serve health care professionals and improve outcomes for patients."