Navigation Links
GelFix(TM) Posterior Spinal Distraction Implant Receives CE Mark
Date:3/8/2010

CRANBURY, N.J., March 8 /PRNewswire/ -- Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant.    A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.

The GelFix device is a one-piece posterior spinal implant made from HPAN, a biocompatible hydrogel which exhibits desirable mechanical properties including compressive resistance with a dynamic response.  The GelFix distraction implant is used as a spacer between the spinous processes to provide separation and prevent nerve pinching.  The product is available in three sizes to fit the typical range of spinal stenosis patients.

The CE mark for this implant follows the approval the company received last year from the Food and Drug Administration (FDA) to market its EnGuard™ Vessel Guard.  The EnGuard device is indicated for use as a protective cover for blood vessels following anterior spine surgery and is composed of the same biocompatible polymer.

The EnGuard Vessel Guard is the first in a series of innovative products based on their proprietary hydrogel technology that the company is launching this year in the United States.

Commenting on these developments, Ann Prewett, President and CEO, said, "The GelFix implant provides a unique, minimally invasive solution for treating spinal stenosis, a leading cause of back pain."   The GelFix device acts as a dynamic spacer, compressing under load yet maintaining separation of the interspinous space.  In this manner, some of the complications associated with rigid spacers such as breakage of the bones of the spinous process or subsidence may be avoided.    

"Our products provide a technologically advanced alternative to the conventional metal and hard plastic implants which have dominated orthopedics and spine to date.   Replication Medical looks forward to entering these markets because we offer the only technology which provides a biomimetic solution to treat these medical conditions," she explained.

The GelFix interspinous implant may not only reduce pain, but also increase the mobility of the patient.   "The key to the procedure is the minimally invasive technique which can be used to implant the device.  We insert the implant between the appropriate spinous processes and in 8-10 hours, the implant increases in size and gives us the stability that we need," said Carl Lauryssen, M.D., one of Replication Medical's surgeon advisors.

The GelFix Posterior Spinal Distraction Implant is not currently approved for sale or distribution in the United States.

ABOUT REPLICATION MEDICAL

Replication Medical, Inc. is a developer of proprietary, hydrogel based products for the spinal market and other surgical applications.   Headquartered in Cranbury, New Jersey, the Company is a leader in the design and development of novel biometic hydrogel implants.  

SOURCE Replication Medical, Inc.

Back to top
'/>"/>
SOURCE Replication Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Alseres Pharmaceuticals Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial
2. Mayo Clinic Clarifies Diagnosis and Treatment for Rare, Serious Blood Vessel Disease of Brain and Spinal Cord
3. Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
4. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
5. Genzyme Genetics Announces Launch of Carrier Testing and Prenatal Diagnosis for Spinal Muscular Atrophy
6. CoreSpine Technologies Expands Spinal Disc Site Preparation Efforts
7. Alseres Pharmaceuticals Announces 12 Month Interim Results from the Phase I/IIa Cethrin(R) Clinical Trial in Acute Spinal Cord Injury
8. Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
9. New Minimally Invasive Surgical Procedure Restores Quality of Life in Patients With Potentially Debilitating Spinal Condition
10. Markers in Blood and Spinal Fluid, and a New Imaging Agent, Show Promise for Early Detection of Alzheimers
11. Neuralstem Licenses Cleveland Clinic Spinal Cord Injection Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... Medical, Inc. (NASDAQ: CGNT), a medical device company that ... urology market, will release financial results for the fourth ... the market open on Thursday, March 9, 2017. ... and webcast to discuss its financial results the same ... Eastern Time (10:00 a.m. Central Time). Darin Hammers ...
(Date:2/23/2017)... 23. Februar 2017 Im Rahmen seiner ... Wirtschaftszone in der südwestlichen chinesischen Provinz Guizhou, 2017 mit dem ... Innovationsplattform aktiv an der Entwicklung einer eingebetteten Hightech-Schlüsselindustrie. ... Continue Reading ... ...
(Date:2/23/2017)... Calif. , Feb. 23, 2017 ... leading the discovery and development of innovative medicines targeting ... full year 2016 financial results on Thursday, March 2, ... host a conference call and webcast on March 2, ... quarter and full year 2016 financial results and provide ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... (PRWEB) February 23, 2017 -- ... to come together to combine its favorite springtime pastime – ... fruit – apples! To celebrate National Nutrition Month, the U.S. ... Madness” bracket tournament – a five-week, five-round online competition spotlighting ...
(Date:2/23/2017)... Los Angeles, CA (PRWEB) , ... February 23, 2017 , ... ... of her Smiling Patriot program today with a new Indiegogo campaign ... dental care to homeless veterans in the Los Angeles area, either as a participating ...
(Date:2/23/2017)... ... 2017 , ... HealthPostures, the desk for standing designer headquartered in Prior Lake, ... the Minneapolis Home and Garden Show which is being held February 24 through 26 ... is the Minneapolis Convention Center. , From its broad line of sit stand ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Carlos ... problems. He has also continued to spiritually evolve, which is the purpose of everyone ... “ Our Spiritual Truths ” (published by Balboa Press) attempts to guide readers to ...
(Date:2/22/2017)... ... February 22, 2017 , ... Our high-octane society ... even the sharpest brain. , Power On, a mental performance enhancer from Modus ... the brain. Each capsule contains Cognizin® Citicoline, a branded form of the brain ...
Breaking Medicine News(10 mins):