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 Advisers Back Cook Medical Stent for Leg Arteries


10/13/2011 6:39:29 PM

Cook Medical's Zilver(R) PTX(R) Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee

U.S. health advisers on Thursday unanimously backed a new Cook Medical stent coated with a common cancer-fighting drug to treat clogged arteries in the thighs. A panel of outside experts to the Food and Drug Administration said the Zilver PTX stent was safe and effective for keeping blood vessels above the knee free from plaque.

GAITHERSBURG, Md., Oct 13, 2011 (BUSINESS WIRE) -- The Zilver(R) PTX(R) Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the Food and Drug Administration's (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee, Cook Medical announced today. The panel convened today in the Washington, DC area and all 11 of its members voted to recommend approval of the device on the basis of its safety, efficacy and acceptable risk profile. The recommendation is the latest step in the regulatory review process that the company hopes will ultimately lead to FDA approval to sell the Zilver PTX stent in the U.S.

"Cook Medical is very pleased that the FDA's Circulatory System Devices Panel has recognized the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the U.S. from the FDA in the coming months," said Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention unit. "Cook Medical is dedicated to continually innovating and delivering medical devices that improve the quality of patient care worldwide, and we wholeheartedly feel Zilver PTX provides a great example of that patient-focused business philosophy."

Following CE Mark approval in 2009, Cook Medical's Zilver PTX Drug Eluting Stent is now available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan, Lyles added.

About Cook Medical

Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50029178&lang=en

SOURCE: Cook Medical

Cook Medical
David McCarty, 812-339-2235 ext. 2387
Director, Global Public Relations
Mobile: 812-322-1805
Dave.McCarty@CookMedical.com
or
Racepoint Group
Cheri Keith, 781-487-4672
Mobile: 781-258-6727
ckeith@racepointgroup.com


Read at Reuters
Read at BusinessWeek
Read at BioSpace.com

   

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