News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Paradigm Spine, LLC Completes Enrollment in Pivotal Clinical Study of coflex(R) Interlaminar Technology


3/29/2010 1:09:09 PM

NEW YORK--(BUSINESS WIRE)--Paradigm Spine, LLC, a developer of innovative non-fusion and fusion spinal implant solutions, announced today that it has completed patient enrollment in an Investigational Device Exemption (“IDE”) pivotal clinical study comparing the coflex® interlaminar technology to instrumented posterolateral fusion in the surgical treatment of spinal stenosis. Data from this trial will be used to support the coflex® interlaminar technology Pre-Market Approval (“PMA”) application. The study is a prospective, randomized and concurrently controlled clinical study involving more than 380 patients at 21 sites within the United States. The coflex® technology, with over 15 years of clinical heritage outside the U.S., has been implanted in more than 50,000 patients, and is selling in over 40 countries worldwide.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES