Paradigm Spine, LLC Announces the Release of Two Independent Prospective Clinical Studies that Substantiate coflex® Interlaminar Stabilization After Decompression for the Treatment of Spinal Stenosis - NewsOn6.com - Tulsa, OK - News, Weather, Video and Sports - KOTV.com |

Paradigm Spine, LLC Announces the Release of Two Independent Prospective Clinical Studies that Substantiate coflex® Interlaminar Stabilization After Decompression for the Treatment of Spinal Stenosis

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

SOURCE Paradigm Spine, LLC

NEW YORK, July 8, 2014 /PRNewswire/ -- Paradigm Spine, LLC, a leading provider of innovative motion preserving spinal publication of two separate independent prospective clinical research studies that address clinical effectiveness of open surgical decompression or laminotomy, and the effect of post decompression interlaminar stabilization including validated outcomes parameters and supportive imaging measurements to convincingly support the improved short term and long term durability of coflex® interlaminar stabilization.

In the recently published study titled "Role of coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis" in the Asian Spine Journal, April 8, 2014, Dr. Naresh Kumar, et al used a prospective and patient randomized cohort comparison study of decompression alone vs decompression supplemented with the addition of coflex® interlaminar stabilization looking at patient reported outcomes and the correlation of these outcomes to imaging over two years after surgery.  The authors noted statistically significant clinical outcome improvement over preoperative status with open surgical decompression and also noted the addition of coflex® statistically improved the outcomes over the decompression only group.  Postoperative imaging studies supported statistically significant maintenance of disc heights and foraminal heights with interlaminar stabilization compared to the decompression only group.[1]

In a separate publication, "coflex Dynamic Distraction Stabilization Device for Lumbar Degenerative Diseases" published in Cureus, January 2, 2014 by Mohamed Mohi Eldin discusses a multicenter prospective case controlled series that reveals significant improvement in patient reported outcomes including back pain improvement and functional stabilization of disc heights and foraminal volume with maintenance of dynamic motion at the index level of surgery.[2]

As these two important independent studies continue to add to the wealth of published literature worldwide, Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, "critical thinking from clinicians throughout the world will help determine the true place for this innovative technology and we are pleased to see studies from different parts of the world contributing to the massive evidence library for coflex® interlaminar stabilization." 

From a patient advocate and surgeon's perspective, Hallett Mathews, MD, MBA, EVP & CMO is impressed with the improved performance of decompressions that are supplemented with the coflex® device.  "Surgeons appreciate the effectiveness of surgical decompression, however we have seen little long term evidence on how these decompressions perform with progressive degenerative disease causing spinal stenosis.  Dr. Kumar's work shows the importance of decompression, and statistically favorable outcomes, that were markedly improved with the addition of coflex® stabilization.  The improved initial results and the durability of the symptom relief at 2 years is impressive.  Simple decompression results without the addition of coflex® were not always sustainable over time.  Interlaminar stabilization clearly leads to improved patient outcomes and value."

About Paradigm Spine, LLC

Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company's signature product is the coflex® interlaminar stabilization device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

[1] "Role of coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis" Naresh Kumar, et al, Asian Spine J. 2014 Apr; 8 (2):161-169.

[2] "coflex Dynamic Distraction Stabilization Device for Lumbar Degenerative Diseases" Mohamed Mohi Eldin (2014-01-02 18:00:00 UTC) Cureus 6(1): e152. doi:10.7759/cureus.152

©2012 PR Newswire. All Rights Reserved.

Powered by WorldNow
News On 6
303 N. Boston Ave.
Tulsa, OK 74103
TULSA'S OWN TM
GREEN COUNTRY'S OWN TM
Oklahoma's Own Newson6.com is proud to provide Oklahomans with timely and relevant news and information, sharing the stories, pictures and loves of Oklahomans across our great state including Tulsa's Own and Green Country's Own.
All content © Copyright 2000 - 2014, WorldNow and KOTV. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms of Service.