Go Back   ISPINE.ORG Forum > Main forums > Abstracts and Articles
FAQ Members List Calendar Search Today's Posts Mark Forums Read

Abstracts and Articles Discuss coflex interlaminar lumbar device study in the Main forums forums; Posted on the ORTHO SuperSite April 1, 2010 Paradigm Spine completes enrollment in clinical study Submit a Comment Print E-...

Reply
 
LinkBack Thread Tools Display Modes
  #1 (permalink)  
Old 04-08-2010, 10:24 PM
Senior Member
 
Join Date: Sep 2006
Location: Calgary, Canada
Posts: 108
Default coflex interlaminar lumbar device study

Posted on the ORTHO SuperSite April 1, 2010
Paradigm Spine completes enrollment in clinical study
Submit a Comment Print E-mail
Paradigm Spine, LLC, a developer of innovative nonfusion and fusion spinal implant solutions, announced in a press release that it has completed patient enrollment in an Investigational Device Exemption 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 in the United States. The coflex technology, with over 15 years of clinical heritage outside the United States, has been implanted in more than 50,000 patients, and is selling in over 40 countries worldwide, the company noted.

The coflex technology is a minimally invasive, non-fusion implant that allows movement of the spine in both flexion and extension, while providing interlaminar stabilization, foraminal distraction and facet distraction, the Paradigm release noted. The coflex is a U-shaped titanium alloy surgical device which is implanted in the interlaminar space following a surgical decompression. It is being evaluated in the United States for use in patients with moderate to severe spinal stenosis, isolated to 1 or 2 levels, in the region of the first to the fifth lumbar vertebrae, specifically L1 to L5, according to the company.

Reginald J. Davis, MD, chief of neurosurgery at Greater Baltimore Medical Center and an investigator in the study explained, “Since the coflex device is a functionally dynamic nonfusion implant, it will provide spine surgeons with the option of utilizing a less invasive, tissue sparing procedure while affording patients significant pain relief all without having to resort to fusion. I look forward to having the coflex device as part of the ‘arsenal’ of surgical options for relief of pain due to spinal stenosis.”
__________________
Outlier cervie - painfree cord compression
Reply With Quote
  #2 (permalink)  
Old 04-09-2010, 06:54 PM
mmglobal's Avatar
Administrator
 
Join Date: Sep 2006
Posts: 2,510
Default

Hope, thanks for posting. I've seen many Coflex procedures over the years (all the way back to when it was still called the Fixano-U!). It's an interesting device that can be used in a variety of configurations. While this can't be done yet in the US, it's been successfully implanted behind ADR, providing stabilization and limiting motion in a neutral range.

Interesting device.
__________________
1997 MVA
2000 L4-5 Microdiscectomy/laminotomy
2001 L5-S1 Micro-d/lami
2002 L4-S1 Charite' ADR - SUCCESS!
2009 C3-C4, C5-C6-C7, T1-T2 ProDisc-C Nova
Summer 2009, more bad thoracic discs!
Life After Surgery Website
President: Global Patient Network, Inc.
Founder: www.iSpine.org
Reply With Quote
  #3 (permalink)  
Old 04-14-2010, 07:06 PM
Keano16's Avatar
Senior Member
 
Join Date: May 2009
Location: Croatia
Posts: 139
Send a message via MSN to Keano16 Send a message via Skype™ to Keano16
Default

Yes, I know several patients with Coflex.

When indicated, its a good solution for spinal stenosis, and in Croatia some surgeons are using it as dynamic stabilization device to treat DDD.
__________________
"The world of spinal medicine, unfortunately, is producing patients with failed back surgery syndrome at an alarming rate"

2005 - 2012: Rich personal experience with spinal disorders and various treatments (surgical, therapeutic, diagnostic)
Co-Founder: Vertebris Internationl Spine Hospital
Founder: Spinoteka - Society for Spine Diseases
Reply With Quote
Reply

Bookmarks

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are On
Pingbacks are On
Refbacks are On



All times are GMT. The time now is 04:38 AM.


Powered by vBulletin® Version 3.7.2
Copyright ©2000 - 2018, Jelsoft Enterprises Ltd.