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

   

FDA Clears OrthoSensor, Inc.'s Verasense Knee Replacement Device


6/19/2013 6:56:19 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

OrthoSensor(TM) Receives FDA Clearance for VERASENSE(TM) Knee System with Limb Alignment

SUNRISE, FL--(Marketwired - June 18, 2013) - OrthoSensor™, Inc., the leader in intelligent orthopedics, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VERASENSE™ Knee System with limb alignment. VERASENSE is the first intraoperative instrument system to combine quantifiable data on limb alignment, implant position and soft tissue balancing for surgeons during total knee replacement surgery.

The VERASENSE Knee System is an intelligent, low-cost, single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. VERASENSE utilizes advanced, proprietary sensor and communications technologies to give surgeons real-time feedback on limb alignment, implant position and soft tissue balance during knee replacement. By delivering this dynamic, quantitative data, VERASENSE empowers surgeons to make evidence-based decisions regarding component placement, limb alignment and soft tissue balance to optimize clinical outcomes and enhance patient satisfaction.

VERASENSE integrates seamlessly within the current surgical workflow and is compatible for use with multiple knee implant systems. VERASENSE enables surgeons, for the first time, to rapidly make a total kinetic (force and motion) assessment of knee function and make adjustments to achieve balance and stability through a full range of motion.

"For the best patient outcomes, a knee must be both properly aligned and balanced; having the ability to quantify these two critical factors with one system is a major advance in total knee arthroplasty," said Kenneth A. Gustke, M.D., Florida Orthopedic Institute. "Inaccurate limb alignment leads to long term wear problems; improper soft tissue balance leads to postoperative pain for patients, as well as instability, stiffness and dissatisfaction. VERASENSE is an accurate, simple and affordable solution to give knee replacement patients optimal short and long term clinical outcomes."

"OrthoSensor's intelligent orthopedic technology has taken knee replacement surgery to a new level of precision that enables improved patient care," said Jay Pierce, OrthoSensor's CEO. "Traditionally, surgeons have relied on conventional instruments, personal judgment, and experience to assess soft tissue balance and limb alignment. VERASENSE advances surgeon decision-making from a feel-based art, to a quantifiable science with a low cost, easy to adopt solution that benefits all health system stakeholders and the patients they serve."

The first generation of VERASENSE with soft tissue balancing capabilities has already been adopted by over 35 orthopedic centers of excellence in the U.S.

About OrthoSensor
OrthoSensor, Inc. (www.orthosensor.com) is developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor's intelligent orthopedic devices utilize advanced sensor and wireless communication technologies with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company's intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, and enable remote monitoring of implant function and overall musculoskeletal health.


Contacts:
Brandy Krier
954-604-4540
bkrier@orthosensor.com

Stephanie Marks
212-867-1762
smarks@lazarpartners.com

Brian Baxter
646-871-8491
bbaxter@lazarpartners.com



Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

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