Data Presented at LINC Confirm the Safety and Effectiveness of Zilver® PTX®
The recently published meta-analysis linking paclitaxel-coated devices and increased mortality didn't include patient-level data.2
Today at the Leipzig Interventional Course (LINC), Cook Medical
participated in significant discussion about the use of paclitaxel to
treat patients suffering from PAD. Through several presentations to
meeting attendees, data supported the use of paclitaxel-coated devices
to help the more than 200 million1 patients globally who are
fighting the disease.
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“We believe industry-wide discussion on topics related to patient safety
and long-term patient outcomes are critically important. In the case of
paclitaxel, we have studied this drug for more than 20 years and tens of
thousands of patients have been treated with Zilver PTX,” said Mark
Breedlove, vice president of Cook Medical’s Vascular division. “The
recently published meta-analysis linking paclitaxel-coated devices and
increased mortality didn't include patient-level data.”2
Cook data demonstrate the safety and effectiveness of the Zilver PTX
Drug Eluting Stent. This includes 479 patients in a 5-year follow-up
randomized controlled trial3. A recently released Japanese
five-year post-market study4 on Zilver PTX showed positive
long-term safety and effectiveness outcomes in challenging real-world
patients.
Professor Michael Dake, the principal investigator for the Zilver PTX
Randomized Controlled Trial, presented at LINC on “Long-term safety
information on Paclitaxel eluting stents - Insights from the Zilver PTX
programme.” After reviewing all patient level data in the Zilver PTX
five-year follow-up, Dake stated that “Cook’s patient level data
demonstrate no increased mortality rates at five years with use of a
Zilver PTX paclitaxel-coated stent versus the use of non-coated stents
and balloons.”
Zilver PTX is indicated for improving luminal diameter for the
treatment of de novo or restenotic symptomatic lesions in native
vascular disease of the above-the-knee femoropopliteal arteries having
reference vessel diameter from 4 mm to 7 mm and total lesion lengths up
to 300 mm per patient.5
Caution: U.S. federal law restricts this device to sale by or on the
order of a physician (or properly licensed practitioner). Use of this
drug-eluting peripheral stent carries the risks associated with
peripheral artery stenting, including vascular complications and/or
bleeding events. Refer to the Instructions for Use (IFU) for full
prescribing information including information on potential adverse
events, contraindications, warnings, precautions, and summary of
clinical data.
Dr. Michael Dake is a paid consultant for Cook Medical.
Find other recent news on Zilver
PTX.
1 Shu J, Santulli G. Update on peripheral artery disease: Epidemiology
and evidence-based facts. Atherosclerosis. 2018 Aug; 275: 379–381.
2 Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of death following
application of paclitaxel‐coated balloons and stents in the
femoropopliteal artery of the leg: A systematic review and meta‐analysis
of randomized controlled trials. Journal of the American Heart
Association. 2018;7:e011245
3 Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with
paclitaxel-eluting stents in the femoropopliteal artery: 5-year results
of the Zilver PTX randomized trial. Circulation.
2016;133(15):1472-1483.
4 Five-year evaluation of Zilver PTX stent in a real-world population
continues to show favourable outcomes. Vascular News Web site. https://vascularnews.com/five-year-evaluation-zilver-ptx-stent/.
Accessed January 20, 2019.
5 Refer to Instructions for Use (U.S. IFU) for clinical data overview
(IFU0118).
About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop
technologies that eliminate the need for open surgery. Today, we are
combining medical devices, biologic materials and cellular therapies to
help the world’s healthcare systems deliver better outcomes more
efficiently. We have always remained family owned so that we have the
freedom to focus on what we care about: patients, our employees, and our
communities. Find out more at cookmedical.com, and
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