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

   

First Human Implant of New Archus Orthopedics, Inc. Facet Replacement System


4/23/2008 8:09:14 AM

REDMOND, Wash., April 23 /PRNewswire/ -- Archus Orthopedics, Inc., announced today that it has successfully completed the first human implant of its TFAS-C(TM) system, the newest addition to the company's product line for treating spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with moderate to severe spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. Archus products replace degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion.

The TFAS-C is indicated for the L3-4 and L4-5 spinal levels and complements the company's TFAS-LS(TM) system, which entered the clinic in late 2007 and addresses the unique anatomy of the L5-S1, "lumbosacral" spinal level. Both systems utilize conventional pedicle screw fixation and join the company's first product, the Total Facet Arthroplasty System(R) or "TFAS(R)", which is anchored by means of bone cement and has been successfully implanted in nearly two hundred patients worldwide, with the vast majority treated in the United States in an ongoing IDE study approved by the U.S. Food and Drug Administration.

The milestone case was performed in Europe by Dr. Scott Webb from the Florida Spine Institute, assisted by Dr. Radu Prejbeanu, Dr. Ioan Branea and Dr. Dinu Vermesan. "The TFAS-C is easy to implant and our first case was very straightforward," said Dr. Webb, a pioneering spine surgeon who performed the first TFAS implantation in 2005, which was one of the earliest facet joint replacement procedures ever completed. "The full product line that Archus has developed for spinal stenosis allows me to treat almost all comers and gives me multiple device options to address variable patient anatomy and pathology," he added.

"The TFAS-C completes our spinal stenosis product line and it is gratifying to see all three devices now in clinical use," said Jim Fitzsimmons, chairman and chief executive officer. While Archus will conduct clinical trials of the TFAS-C and other new products to gain marketing approval in the United States, the company's entire device family is already cleared for commercialization in the European Union. "We expect to complete marketing trials this year and plan to pursue a broad but controlled launch in Europe next year," said Fitzsimmons.

About Archus Orthopedics

Founded in July 2001, Archus Orthopedics is a privately held company developing a family of reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints. Archus has received venture capital funding from MPM Capital, InterWest Partners, Polaris Venture Partners and Johnson & Johnson Development Corporation, in cooperation with DePuy Spine.

CONTACT: Jim Fitzsimmons, Chairman and Chief Executive Officer of Archus
Orthopedics, Inc., +1-425-284-3650, jfitzsimmons@archususa.com

Web site: http://www.archususa.com/



Read at BioSpace.com

   

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