GAITHERSBURG, Md.–(BUSINESS WIRE)–The Zilver® PTX® 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
Administrations (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 FDAs 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 Medicals 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 Medicals 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.