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

   

VertiFlex Announces FDA Clearance of Two Key Additions to Technology Portfolio


1/8/2013 9:50:09 AM

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, today announced FDA 510(k) clearance of two new products to its portfolio: The Totalis™ Direct Decompression System and UniVise™ Spinous Process Fixation System.

“These regulatory clearances represent important milestones for VertiFlex® as we rapidly expand our portfolio of innovative interspinous technologies,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “We leveraged the unique benefits of our Superion® Interspinous Spacer System and strong IP position, to develop these differentiated products to address two significant market opportunities. This accomplishment highlights the company’s core strengths and fundamental commitment to provide physicians with multiple options to best treat patients in the least invasive methods possible.”

The Totalis™ Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. The system utilizes VertiFlex’ proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing targeted bone and soft tissue. The Totalis™ Direct Decompression System was 510(k) cleared by the FDA in November, 2012.

The UniVise™ Spinous Process Fixation System is a spinal implant system designed to provide fixation of the spinous processes as an adjunct to lumbar spinal fusion. The system leverages the company’s core technology and intellectual property. The UniVise™ system is the least invasive spinous process fixation system available and was 510(k) cleared by the FDA in December, 2012.

The Superion® Interspinous Spacer System (ISS) is a motion-preserving spinal implant system for the treatment of moderate lumbar spinal stenosis. Superion® is the most advanced and least invasive ISS available or in development for performing indirect decompressions of the lumbar spine. The Superion® implant is delivered from a posterior midline approach through a proprietary interspinous access system developed by VertiFlex®. The small incision can be closed with a single suture and performed under local anesthesia on an outpatient basis. Once in place, it may reduce pressure on the nerves that cause pain and allow the return to a more active lifestyle. Superion® has been CE marked since 2007 and is currently an investigational device in the U.S. Enrollment completed in the Superion® pivotal IDE trial with 470 patients in December, 2011. It has been implanted in over 2000 patients worldwide.

About VertiFlex®, Inc.

VertiFlex® is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex® has developed a proprietary, minimally invasive interspinous access platform for performing both indirect and direct decompressions of the lumbar spine. These technologies fill the MIS procedural gap in the stenosis treatment continuum between conservative care and traditional spine surgery. This provides new options for interventional spine physicians and less invasive options for traditional spine surgeons to treat patients who would otherwise undergo more invasive surgery. To date, VertiFlex® has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.

Contacts

VertiFlex®, Inc.
Scott Lynch
949-940-1400
info@vertiflexspine.com
www.vertiflexspine.com


Read at BioSpace.com

   

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