Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant
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 the United States and European Union demonstrated that ETHICON OMNEX provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON OMNEX patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)
ETHICON OMNEX Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)
ETHICON OMNEX Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON OMNEX Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.
About ETHICON Biosurgery
Ethicon, Inc.'s Biosurgery Business, with nearly 50 years of proven experience in hemostasis, continues its dedication with cutting edge technologies that are supported by evidence.
Ethicon, Inc. is committed to advancing the future of biosurgery. Ethicon, Inc. offers the world's most complete line of absorbable hemostats, including proprietary oxidized, regenerated cellulose hemostats, absorbable gelatin powder and sponges, a hemostatic matrix, topical human thrombin, and human fibrin sealant.
About Ethicon, Inc.
Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the Company's vision: Restoration of body and of life. For more information, visit www.ethicon.com.
* Paid consultant to Ethicon, Inc.
(1) Closure Medical Corporation. Protocol Report 06TR073; dated 12/08/2006.
(2) Long-term follow up of patients enrolled in a pivotal multi-center study of vascular sealant use in vascular reconstruction as an adjunct to conventional techniques to achieve hemostasis. Closure Medical Corporation. Clinical Study Report 08CS004; dated 12/16/2009.
SOURCE Ethicon, Inc.