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:5/25/2016)... NEW YORK , May 25, 2016  According ... devices reached $381 billion in 2015.  Though these ... still plenty of opportunity for success for companies ... end, in search of new growth prospects medical ... revenue on research and development (R&D) than do ...
(Date:5/25/2016)... -- MedDay, a biotechnology company focused on the ... entitled "High doses of biotin in progressive multiple sclerosis: extension ... Professor Ayman Tourbah , Principal Investigator of the Phase ... of Neurology (EAN) in Copenhagen, Denmark . ... place on Sunday, 29 May 2016 from 14:45 to 16:15 ...
(Date:5/24/2016)... , May 24, 2016 ... beide primären Endpunkte und ... Überlegenheit in ‚ausgezeichneter plus guter ... Colons    ,      (Logo: ... gab heute neue positive Daten von der MORA-Studie ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... ... a significant negative impact on long-term patient survival, reports a team of UPMC ... online this week in the Journal of Thoracic and Cardiovascular Surgery, provide critical ...
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its line of ... Warner, New Hampshire at the MadgeTech headquarters. With products sold in more than 100 ... government agencies, including NASA. , In 2012, NASA strategically set up 17 RHTemp101A ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will ... Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public ... Retina Group of New York , is a Board Certified ophthalmologist who ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... In an effort to provide hair restoration ... to both Snapchat users and those who do not use the app. Dr. Mohebi, the ... new page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of ... today announced the organization has earned its ISO 13485 certification, indicating the company’s ... with all rules and policies associated with ISO quality standard 13485. , ...
Breaking Medicine News(10 mins):