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Product approval

FDA approves Ethicon’s Vistaseal Dual Applicator devices

Vistaseal Dual Applicator is the first product to emerge from recent strategic partnership between Ethicon and Grifols

Ethicon has received 510(k) clearance from the FDA for its Vistaseal open and laparoscopic Dual Applicators (35cm and 45cm), three next generation airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding. 

These biosurgery products are the first to emerge from a recently forged long-term strategic partnership between the global device maker and Grifols, a world leader in the production 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 haemostats with the goal of reducing complications and improving the standard of care.

“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, Worldwide Biosurgery, 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.”

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 standardise the use of adjunctive haemostats 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 haemostats that address surgical bleeding, the company claimed.

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