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

   

Stanmore Implants Worldwide Receives US FDA Approval for its JTS Non-invasive Extendible Implant


6/24/2011 9:39:18 AM

LONDON, June 24, 2011 /PRNewswire/ -- Stanmore Implants ("Stanmore"), specialists in the design and manufacture of patient specific implants for complex orthopaedic reconstructions, announces that it has received US FDA 510k approval for its Juvenile Tumour System ("JTS") non-invasive extendible distal femoral replacement ("JTS implant"), for use in paediatric orthopaedic oncology surgery.

The JTS implant is used to replace large sections of the distal femur (thigh bone) that has been removed during surgery, often to treat cancer. Previously patients had to undergo multiple, painful surgeries in order to lengthen their implants as they grew. The JTS implant uses an electromagnetic device in order to lengthen the prosthesis without the need for surgery, anaesthesia or sedation, thus reducing the risk of complications.

In November 2002 the first patient, a 13-year-old girl received the JTS non-invasive extendible implant in the UK. Today she has reached skeletal maturity with legs of equal length. Since then over 240 devices have been implanted at specialist centres in 15 countries worldwide. Each implant is designed and manufactured specifically for the recipient patient by the team at Stanmore.

The JTS implant also has significant health economic benefits. A recent US study identified that it costs US$267 to undertake a non-invasive lengthening procedure compared to approximately US$8,000 if surgery is required. Lengthening procedures are undertaken regularly and can be undertaken in doctors' surgeries or outpatient departments.

Brian Steer, Executive Chairman of Stanmore, said:

"Gaining approval in the key US market is a major achievement for Stanmore. Having used the product for nine years in the European markets we are absolutely confident of the product's ability to significantly improve patient outcomes and quality of life by negating the need for repeated surgery in children. This has very clear health economic repercussions and as such we look forward to introducing this product in the United States during the next few months."

Stanmore is now focused on introducing this product across the US and is in the process of assembling a specialist sales team to market the product to orthopaedic oncology surgeons.

Stanmore Implants Worldwide

Stanmore Implants Worldwide is an innovative orthopaedic business focused on the design and manufacture of both bespoke and modular implants for limb sparing and complex primary and revision joint replacement.

Stanmore designs, manufactures and markets a custom implant service alongside a portfolio of orthopaedic implants for limb salvage and complex joint replacement, and is known for creating some of the world's most successful implants.

Stanmore acquired its robotic bone preparation technology through the acquisition of Acrobot, a medical devices company specialising in computer assisted orthopaedic surgery in August 2010.

SOURCE Stanmore Implants



Read at BioSpace.com

   

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