Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today.
The 510(k) clearance covers three Vistaseal open and laparoscopic dual applicators (35 cm and 45 cm). The companies expect to launch the sealant in the U.S. later this year, with the product also available in other select markets under the name Veraseal.
Vistaseal sealant combines two plasma proteins, fibrinogen and thrombin, and offers another tool for surgeons to stop mild to moderate bleeding during procedures.
“Grifols is committed to applying its plasma leadership to its collaboration with Ethicon, whose strengths in device technology and market success in reaching millions of patients worldwide enable us to make important advances in biosurgery and the control of surgical bleeding,” Eduardo Herrero, president of Grifols Bioscience Industrial Group, said in a news release.
The partnership also included the anticipated use of Grifols’ lyophilized thrombin, a clotting protein, in Ethicon’s existing Surgiflo hemostatic matrix, providing another option for surgeons to facilitate and induce clotting during surgery.
Officials at both companies envision the partnership producing more advances in the field of adjunctive hemostats in the future.
“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,” said Oray Boston, president of worldwide biosurgery at Ethicon.
“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,” Boston said.