BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

NLT SPINE Receives FDA 510(k) Clearance for its Discectomy System, eSPIN


9/20/2012 6:29:38 AM

Kfar Saba, Israel (September 20, 2012) – NLT SPINE, a developer of products for Minimally Invasive Spine Surgery (MISS) and percutaneous procedures, announced today that its eSPIN powered discectomy system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device, together with PROW FUSION, is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The system bears CE Mark and has been successfully used in Europe.

eSPIN addresses several challenges associated with manual disc preparation instruments. NLT SPINE demonstrated the following benefits of eSPIN:

• Significant disc evacuation in the contra-lateral side of the disc

• 67% more disc volume removed compared to standard instruments

• 83% fewer instrument passes by the exiting nerve

“eSPIN is well suited for minimally invasive spine surgery offering a predefined, consistent and repeatable procedure,” said Didier Toubia, CEO, NLT SPINE. “Together with the PROW FUSION lumbar interbody fusion system, NLT SPINE offers a complete procedural solution. We are very pleased to announce that yet another NLT SPINE product has been cleared by the FDA, and our aim is to continue to develop innovative capabilities and technology that address complete procedural solutions for minimally invasive spine surgery.”

The eSPIN system consists of a set of single use cutting tips, a hand-held instrument, a motor adaptor and a set of access and positioning instruments.

For more information about the company and technology please visit http://www.nlt-spine.com

About NLT SPINE

NLT SPINE specializes in the development of innovative Minimally Invasive Spinal Surgery (MISS) and percutaneous procedures for treating degenerative spinal conditions. The company’s vision is to improve patient care and reduce total treatment costs by shifting from traditional open surgical routines to MISS, employing new methods and technologies to enhance usability and outcomes.

Led by top international leaders in spinal surgery, NLT SPINE holds a wide portfolio of pending and issued patents that cover the non-linear core technology and related implant and instrument technologies.

Media contact:

Tom Keegan

Vice President Business Development and US Marketing

tom.k@nlt-spine.com

Tel: 508-272-7750



Read at BioSpace.com

   

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