News | September 13, 2011

FDA Discusses Recommendation for First Drug-Eluting Peripheral Stent

September 13, 2011 – An U.S. Food and Drug Administration’s (FDA) will discuss recommendations for Cook Medical Zilver PTX self-expanding drug-eluting peripheral stent at its Oct. 13, 2011, meeting in Gaithersburg, Md. The Circulatory System Devices Panel of the Medical Devices Advisory Committee will provide advice and recommendations to the agency on FDA's regulatory issues.

The committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the Cook Zilver PTX. The self-expanding nitinol stent is coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder or excipient at a dose density of 3 micrograms/square millimeter. It is available in diameters ranging from 5 to 10 mm and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 French  (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the Zilver PTX expands to establish and maintain patency in the stented region. 

The proposed indications for use are treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 to 9 mm and total lesion lengths per patient of 280 mm.

The FDA is not bound to recommendations made by the panel, but usually follows its recommendations. If cleared by the FDA, the Zilver PTX would become the first self-expanding drug-eluting stent, the first drug-eluting stent for peripheral leg vessels and the first drug-eluting stent that does not use a polymer to carry or control the elution of the drug in the United States.

For more information:


Related Content

Medtronic Launches 2 mm Onyx DES
Technology | Stents Drug Eluting | February 26, 2018
February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S.
Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
The Abbott Absorb Bioresorbable Vascular Scaffold (BVS) bioabsorbable stent.

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS).

Feature | Stents Drug Eluting | January 17, 2018 | Dave Fornell
There was no shortage of interest in bioresorbable stent technologies at the many sessions offered on this topic or b
Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System
Technology | Stents Drug Eluting | December 13, 2017
Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of...
The Xience Sierra stent.
Technology | Stents Drug Eluting | November 09, 2017
November 9, 2017 — Abbott received European CE mark for Xience Sierra, the newest generation of the company's Xience
Synergy Stent With Shorter DAPT Superior to Bare-Metal Stent in Elderly Patients
News | Stents Drug Eluting | November 06, 2017
November 6, 2017 — Elderly patients undergoing...
Biotronik Orsiro DES Shows Low Five-Year Event Rates
News | Stents Drug Eluting | November 03, 2017
November 3, 2017 — Biotronik's Orsiro...
Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Image courtesy of OrbusNeich

News | Stents Drug Eluting | November 01, 2017
OrbusNeich reported results from the REDUCE trial in the Late-Breaking Clinical Trial session at the 29th annual...
News | Stents Drug Eluting | October 25, 2017
Elixir Medical Corp. announced it will unveil a new metallic drug-eluting stent (DES) platform at this year’s...
Overlay Init