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Zilver® PTX®: Transparency | 合法醫療器材資訊網

Zilver® PTX®: Transparency

2020年10月2日—CookMedicalisprovidingourextensivelong-termdataonZilverPTX,ourdrug-​elutingstent.ZilverPTXisapaclitaxel-coatedstentthatwas ...

 Zilver® PTX®: Transparency

Cook Medical is providing our extensive long-term data on Zilver PTX, our drug-eluting stent. Zilver PTX is a paclitaxel-coated stent that was approved by the FDA in 2012 through the premarket approval process.

Dr. Michael Dake et al. recently published a peer-reviewed article analyzing Zilver PTX patient-level data from two large studies with long-term follow-up to determine whether there was an increased mortality risk due to paclitaxel. See the results. View Article[1]

View Cook Medical’s updated letter to physicians on paclitaxel[2]

The FDA’s initial concern was in response to a meta-analysis[3] published in the Journal of the American Heart Association regarding mortality rates related to the use of paclitaxel-coated stents and balloons. The meta-analysis ...

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Zilver® PTX® Drug | 合法醫療器材資訊網
Indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee ... Read More
Zilver® PTX®: Transparency | 合法醫療器材資訊網
2020年10月2日 — Cook Medical is providing our extensive long-term data on Zilver PTX, our drug-​eluting stent. Zilver PTX is a paclitaxel-coated stent that was ... Read More
Zilver PTX | 合法醫療器材資訊網
Zilver PTX is the only polymer-free SFA drug-eluting stent. Our proprietary, polymer-free coating process is shown to be safe and effective while eliminating the ... Read More
Cook Medical's Zilver® PTX® Earns FDA Approval As First ... | 合法醫療器材資訊網
2012年11月15日 — Zilver PTX is made of nitinol, a“shape memory” metal alloy, and is engineered to withstand the dynamic forces of the superficial femoral artery ( ... Read More
P100022c.pdf | 合法醫療器材資訊網
The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding stent made of nitinol and coated with the drug paclitaxel. It is a flexible, slotted tube that is. Read More
Long | 合法醫療器材資訊網
由 S Cipollari 著作 · 2018 · 被引用 14 次 — Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels- ... Read More
Paclitaxel | 合法醫療器材資訊網
由 MD Dake 著作 · 2020 · 被引用 27 次 — Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3​, post-market surveillance study. Read More
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