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:9/6/2017)... -- Eli Lilly and Company (NYSE: LLY ... galcanezumab and lasmiditan, two investigational treatments for migraine, at ... taking place Sept. 7-10 in Vancouver ... data from an open-label study evaluating the safety and ... 240 mg) for the prevention of migraine. Galcanezumab is ...
(Date:9/5/2017)... Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ) (TASE: ... on the development of oral drug delivery systems, announced ... the U.S. Food and Drug Administration (FDA) regarding ORMD-0801, ... At the meeting, the FDA gave ... ORMD-0801, would be a Biologics License Application (BLA).  Such ...
(Date:8/29/2017)... , Aug. 29, 2017 ivWatch, LLC, the leading provider ... infiltrations, announced it has been awarded an Innovative Technology contract from ... the country. ... device to aid in the early detection of peripheral IV infiltration ... The Innovative Technology contract ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... September 22, 2017 , ... First Choice ... celebrating the one year anniversary of its Houston-Fallbrook facility. , “We are ... Facility Medical Director of First Choice Emergency Room Houston-Fallbrook. “It has been a ...
(Date:9/22/2017)... ... ... “Letters From Home”: a moving compilation of letters that remind readers of the ... is the creation of published author, John Allred, a passionate leader of ministry to ... who has traveled and ministered on four continents. , “It is my hope and ...
(Date:9/21/2017)... , ... September 21, 2017 , ... With ProSlideshow Portrait ... and easy to do. Users can select from up to two layers of subject ... click of a mouse all within Final Cut Pro X. , With ...
(Date:9/21/2017)... , ... September 21, 2017 , ... ... learn with Infinity Behavioral Health Services for professionals in the addiction treatment industry ... Payer Audit . , Insurance companies and state and federal governments are ...
(Date:9/21/2017)... ... September 21, 2017 , ... Bill Howe Plumbing’s mission is to create an ... to the community. For over 37 years, they have operated with their mission at ... in San Diego. They were chosen as the Best San Diego plumber in ...
Breaking Medicine News(10 mins):