Ethicon announces 510(k) clearances for devices that deliver biologics to address surgical bleeding
VISTASEAL Dual Applicator is the first product to emerge from recent strategic partnership between Ethicon and Grifols, maker of plasma-derived medicines says Johnson & Johnson Medical Devices Companies, which announced that Ethicon has received 510(k) clearance from the Food and Drug Administration (FDA) for its VISTASEAL open and laparoscopic Dual Applicators (35 cm and 45 cm). These three next generation airless spray devices combine biologics with device technology to address mild to moderate surgical bleeding.
Grifols developed the Vistaseal Fibrin Sealant (Human) and Ethicon’s devices are designed to deliver the two biological components of the product. Beyond VISTASEAL, the partnership with Grifols will provide a supply of thrombin for Ethicon’s current products. In the future, it will mean even more advances in the field of adjunctive hemostats with the goal of reducing complications and improving the standard of care.
Bleeding-related complications and perioperative fluid and air leaks adversely affect patient outcomes and increase healthcare costs. Studies show patients suffer from a growing number of comorbidities and other factors that increase the risk of surgical bleeding. An estimated 32 to 68 percent of cases in open surgery procedures experience disruptive bleeding events.
Ethicon is working to standardize the use of adjunctive hemostats and sealants by offering the most appropriate product for each bleeding and leak site and situation. It is the only medical device company that provides a full range of both primary and adjunctive hemostats that address surgical bleeding.
