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

   

ArthroSurface HemiCAP(R) Focal Knee Resurfacing Implant Receives FDA Approval to Move into Final Investigational Stage


9/8/2008 7:25:35 AM

FRANKLIN, Mass., Sept. 5 /PRNewswire/ -- Arthrosurface, Inc. (http://www.arthrosurface.com), the developer of less-invasive joint resurfacing systems, announced that it has received approval from the U.S. FDA to begin its pivotal investigation for its line of focal knee resurfacing implants. The FDA stated that "there are no outstanding safety concerns" with the device and granted Phase III initiation.

Arthrosurface has been evaluating the safety and efficacy of its HemiCAP® implants for focal femoral condyle defects under an ongoing U.S. FDA IDE investigation. "We are very pleased with our 2 year results in the feasibility study. Our data has demonstrated remarkable improvement in pain and function in a challenging middle-aged patient population," said Matthias R. Schurhoff, MD, Vice President of Clinical Operations and Scientific Affairs.

With the HemiCAP® knee implant, the company is targeting a subgroup of knee patients, typically between the ages of 40 and 60 years, who have focal condylar defects and are likely to undergo knee replacement surgery in the future. HemiCAP® resurfacing is intended to bridge the gap between biologic procedures and conventional joint replacement. Arthrosurface's minimally invasive resurfacing system allows for preservation of healthy tissue and joint structures by limiting treatment to localized defects using a shallow inlay implant that is matched to the patient's own unique joint surface anatomy. "Maintaining the overall joint integrity and avoiding early tissue loss through arthroplasty bone cuts may provide a significant benefit for patients in the long-term management of joint degeneration," commented Steven Ek, COO.

With this Phase III study approval, the company is moving one step closer to bringing this new treatment option to U.S. patients.

The HemiCAP® knee implant, which has been in clinical use outside the U.S. for over 4 years, is the smallest or perhaps earliest surgical intervention within the company's comprehensive knee resurfacing catalogue of products. Together with the company's currently globally-marketed UniCAP(TM) unicondylar knee resurfacing and patello-femoral resurfacing implants, the company offers a unique family of resurfacing interventions designed to treat a variety of knee disorders.

Based on the same platform technology, the company also globally markets products in other major joints and extremities.

Source: Arthrosurface, Inc.

Read at BioSpace.com

   

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