Navigation Links
Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant
Date:7/7/2010

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Samplify Expands Global Presence; Opens China Office
2. Millennium Pharmacy Expands in New Jersey
3. Max Neeman International Expands Data Management Services with Conversion Into CDISC Standard Data Model
4. Action Fabricators Expands its Footprint in the Healthcare Industry With the Launch of Laminin Medical Products
5. Celator® Pharmaceuticals Expands Research Agreement With Cephalon, Inc.
6. Advanced Life Sciences Expands Collaboration with U.S. Government to Study Restanza(TM) as Treatment for Sexually Transmitted Infections
7. MoleSafe USA Expands Services to Leading Cancer Facilities at St. Josephs/Candler and CentraState Medical Center
8. Waters Expands Xevo MS Instrument Platform With Next-Generation Mass Spectrometers
9. West Haven Firm Expands Biomedical Disposal Program with Community Economic Development Fund
10. Connectyx Retains Services of CP Capital Securities as It Expands Its Presence in the $5 Billion US Electronic Health Record Market
11. SynCo Expands Agreement with OncoMed Pharmaceuticals to Manufacture Cancer Stem Cell Antibodies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 8, 2016 KEY FINDINGS ... of the market in 2016 and is expected to ... attributed to a large number of surgical procedures that ... largest share in the patient temperature management market.) Patient ... reducing loss of blood during surgeries, lowering the risks ...
(Date:12/8/2016)... Research and Markets has announced the addition ... Adhesion Type, Application, Usability - Forecast to 2025" report to ... , , ... poised to grow at a CAGR of around 3.2% from 2015 ... witnessing include advancements in extracellular microelectrode arrays and intracellular microelectrodes, research ...
(Date:12/8/2016)... 2016  Valeant Pharmaceuticals International, Inc. (NYSE: ... announced positive results from a Phase 3, multicenter ... safety and efficacy of IDP-118 (halobetasol propionate and ... Within the Phase 3 study ... psoriasis, IDP-118 showed statistical significance to vehicle with ...
Breaking Medicine Technology:
(Date:12/9/2016)... New York, NY (PRWEB) , ... December 09, 2016 , ... ... that raises awareness for organ transplantation while encouraging readers to sign up as an ... for a lifesaving organ transplant. , An organ donor can save up to ...
(Date:12/9/2016)... ... 2016 , ... "I had a terrible time trying to get my grandson ... if the nebulizer had a more child-friendly design, then children would be more likely ... patent-pending NEBY to avoid the need to deliver medication via a nebulizer mask. The ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... distinction by the Undersea and Hyperbaric Medical Society (UHMS), the leading authority in ... and patient safety. Only a few hospitals and facilities have earned this distinction. ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... pleased to announce that “Natural Language Processing–Enabled and Conventional Data Capture Methods for ... JMIR Medical Informatics . , Results of the comparative usability study demonstrate ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... CURE Media ... centers and advocacy groups, has aligned with Upstage Lung Cancer in efforts to combat ... the announcement, Michael J. Hennessy, Jr said, “CURE Media Group is honored to team ...
Breaking Medicine News(10 mins):