Bloomington, IN – Cook Medical will present data supporting the submission for its Zilver® PTX® Drug-Eluting Stent in the superficial femoral artery (SFA) to the Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee on October 13, 2011. Stanford University physician Michael Dake, M.D., the global principal investigator of Cook Medical’s Zilver PTX Drug-Eluting Stent clinical study, will present and highlight the data points.
“We’re excited to present the data on Cook Medical’s Zilver PTX Drug-Eluting Stent. The uncoated version of the Zilver self-expanding nitinol stent is approved and commercially available in the United States as a bare metal stent to treat lesions in the iliac arteries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “We look forward to presenting this combination therapy device to the panel.”
FDA Panel will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the Zilver PTX Drug-Eluting Stent.
October 13, 2011
8:00 a.m. – 6:00 p.m. ET
Hilton Washington DC
620 Perry Pkwy
Gaithersburg, MD 20877
Dr. Michael D. Dake, chief of interventional radiology at Stanford University Medical Center Dr. Gary Ansel, director, Center for Critical Limb Care, Riverside Methodist Hospital
Rob Lyles, vice president and global leader of the Peripheral Intervention division, Cook Medical
Ted Heise, Ph.D., vice president, regulatory scientific affairs, Cook Medical
Anthony Ragheb, PhD, vice president, MED Institute
April Lavender, senior vice president, global regulatory affairs, Cook Medical
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