Navigation Links
Biomerix Granted CE Mark for its REVIVE™ Soft Tissue Repair Mesh
Date:1/24/2011

FREMONT, Calif., Jan. 24, 2011 /PRNewswire/ -- Biomerix Corporation announced today that it has received CE Mark approval for its REVIVE™ soft tissue repair mesh allowing for the marketing of REVIVE in all European Union member (EU) states.    REVIVE received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2009.

REVIVE is constructed of the Biomerix Biomaterial™, a proprietary, biointegrative synthetic tissue scaffold.  This unique structure is designed to play a role similar to that of the body's extracellular matrix, supporting organized tissue ingrowth.  The device is designed for repair and reinforcement in a variety of soft tissue procedures such as inguinal hernias.

Over 700,000 inguinal hernia repair procedures are performed annually in Europe.  Inguinal hernias occur when soft tissue, usually part of the intestines, protrudes through a weak point or tear in the lower abdominal wall.  Synthetic mesh is commonly used to reinforce the repair and support the surrounding tissue.  REVIVE is designed to facilitate robust tissue ingrowth, while minimizing the scarring response typically associated with implantation of a mesh.  Mesh contraction and intense scarring can lead to persistent groin pain.  Initial feedback from users of REVIVE has confirmed excellent ease of use and conformability to the anatomy.  The soft, pliable nature of the mesh easily adapts to the anatomy allowing for easy delivery, positioning and fixation of the mesh.

"This latest approval represents another important milestone in Biomerix's plans to develop innovative products based on its proprietary materials and capabilities," said Kenneth G. Hayes, President and CEO of Biomerix Corporation.  "REVIVE will be distributed in the EU by Medline Industries pursuant to our exclusive distribution agreement."

About Biomerix

Biomerix Corporation develops and manufactures novel and proprietary materials to meet the needs of the medical, industrial, and consumer markets.  Founded in 2001, Biomerix began developing a new class of polymeric material designed to support the tissue healing process.  By 2004, the Company achieved a significant breakthrough and created the proprietary Biomerix Biomaterial™, a revolutionary biointegrative synthetic tissue scaffold.  The Biomerix Biomaterial is a non-resorbable, cross linked, reticulated, polycarbonate polyurethane-urea consisting of an open-cell, three-dimensional, interconnected macroporous structure.  This unique scaffold translates into an ability to support predictable, organized fibrovascular tissue ingrowth.  The Biomerix Biomaterial is designed to play a role similar to the body's extracellular matrix (ECM), through the main phases of inflammation, proliferation, and remodeling.

To maximize the value of its material platform technology and capabilities, Biomerix has implemented a multifaceted business model.  The Company selectively develops and manufactures OEM finished medical devices using the Biomerix Biomaterial, supplies the Biomerix Biomaterial as a component for other medical devices; and collaboratively designs and develops custom materials with select business partners. For more information please call 888.308.3620 or visit www.biomerix.com.


'/>"/>
SOURCE Biomerix Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Biomerix Ventral Hernia Repair Mesh Receives FDA 510(k) Clearance
2. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
3. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
4. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
5. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
6. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
7. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
8. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
9. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
10. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
11. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... 2017 The U.S. Food and Drug Administration today ... (CIC) in adult patients. "No one medication ... Julie Beitz , M.D., director of the Office of ... and Research. "With the availability of new therapies, patients and ... condition." ...
(Date:1/19/2017)... CITY, N.J. , Jan. 19, 2017 ... over $100 for their medication when a pharmacy just ... same exact prescription.  To alleviate this problem Medicationdiscountcard.com ... and patients to see exactly how much their medication ... Comparison Shopping Made Easy ...
(Date:1/19/2017)... 19, 2017 Accuray Incorporated (Nasdaq: ... Systems continue to set the bar for excellence in ... overall user satisfaction rating among radiation treatment delivery systems ... Buyline Market Intelligence Briefing™. The most recent ratings trend ... among industry peers for 11 of the past 12 ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... ATP Science, an Australian-based ... recently attended the January ECRM Trade Show in Hilton Head, SC, benefiting from ... large range of supplements that keep the body functioning at its peak performance ...
(Date:1/20/2017)... ... 20, 2017 , ... "TransFlare 4K Mystique comes with 44 colorful mysterious transitions ... said Christina Austin - CEO of Pixel Film Studios. , TransFlare 4K Mystique ... Mystique lens flare and light leak transitions have a very high-dynamic range for super ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “The Angel”: ... the Lord has set out for each of his children. “The Angel” is the ... School of Music in New York City, and impassioned writer. , When asked of ...
(Date:1/20/2017)... ... January 20, 2017 , ... D R Burton Healthcare Products ... was featured in a study indicating superior performance against competitive products in secretion ... Three Oscillating Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Knowledge is God’s Lighthouse”: a moving and ... God’s Lighthouse” is the creation of published author, Gene Gaapf, a retired truck driver, ... , “I have been writing since high school and have many different titles,” Gaapf ...
Breaking Medicine News(10 mins):