SOMERVILLE, N.J., July 7 /PRNewswire/ — Ethicon, Inc., a
worldwide leader in surgical care, announced today the introduction
of 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.
ETHICON™ OMNEX™ creates a strong, flexible physical
seal independent of the body’s clotting mechanisms. It is
proven in an ex-vivo model to be two-to-four times as strong as
other surgical sealants, is ready for use in less than 30 seconds,
and proven to seal to ePTFE grafts and bond securely to friable
vessels.(1)
“A basic rule of patient safety and excellent outcomes is to
prevent unnecessary bleeding during and immediately after surgery,”
said Alan B. Lumsden MD, Medical
Director of the Methodist DeBakey Heart & Vascular Center and
the Chairman of the Department of Cardiovascular Surgery at The
Methodist Hospital in Houston.*
“The availability of an effective surgical sealant such as
ETHICON™ OMNEX™ provides surgeons with a valuable new
tool that is clinically proven to decrease the time it takes to
seal the surgical site, including ePTFE grafts, and prevent leakage
from occurring.”
ETHICON™ OMNEX™ is clinically proven to
significantly decrease time to hemostasis based on clinical trials
conducted to support its safety and effectiveness. Specifically,
results from a pivotal, randomized, controlled, open-label,
multi-center trial of 151 patients at 13 centers in ‘/>”/>