Ethicon, Inc. introduces the ETHICON™ OMNEX™ Surgical Sealant, ETHICON™ Biosurgery’s first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON™ OMNEX™ Surgical Sealant. According to the company, ETHICON™ OMNEX™ features:
- The ability to create a strong, flexible physical seal independent of the body’s clotting mechanisms.
- The ability to be ready for use in less than 30 seconds and to seal to ePTFE grafts and bond securely to friable vessels.
- Clinically proven to decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness.
- Proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.
- Intended for use as an adjunctive sealant and is not to be used in place of sutures, staples or mechanical closure.
For more information, visit www.ethicon.com