Ethicon sees devices for surgical bleeding receive FDA clearance

Johnson & Johnson Medical Devices Companies has announced that Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VistaSeal open and laparoscopic Dual Applicators (35 cm and 45 cm), three airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding.  

These biosurgery products emerge from a recently forged long-term strategic partnership between the global device maker and Grifols, a producer of plasma-derived medicines. 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. 

Oray Boston, president, worldwide biosurgery, Ethicon said: “Ethicon’s biosurgery portfolio offers a broad array of technologies that address intraoperative bleeding, which is among the most difficult challenges facing surgeons and their patients. Our partnership with Grifols will leverage our strengths in device technology with Grifols’ strengths in plasma-derived medicines to expand our portfolio and accelerate innovation in the fast-growing field of biosurgery.” 

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 32-68% of cases in open surgery procedures experience disruptive bleeding events.