Cook Medical Responds to Updated FDA Recommendations on Paclitaxel Devices to Treat PAD

August 7, 2019—Cook Medical, manufacturer of the Zilver PTX paclitaxel-eluting peripheral stent, responded to the FDA's updated communication to health care providers on paclitaxel-coated devices used to treat peripheral arterial disease (PAD), which was issued on August 7.

The FDA update provides the latest information on the FDA analysis of long-term follow-up data from premarket trials and provides summary information from the June 19–20, 2019, public meeting of the Circulatory System Devices Panel of the FDA Medical Devices Advisory Committee that discussed and made recommendations on the potential late mortality signal after treatment with paclitaxel-eluting devices in the femoropopliteal artery. In addition, it includes recommendations to health care providers for assessing and treating patients with PAD using paclitaxel-coated devices.

Cook’s presentation to the FDA Advisory Panel is available online here.

The company noted that the FDA recommends that physicians discuss the risks and benefits of all available PAD treatment options with patients and determine if the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.

According to Cook Medical, the Zilver PTX peripheral drug-eluting stent is supported by long-term data, showing a sustained clinical benefit with > 40% reduction in both restenosis and reintervention through 5 years. More than 300,000 Zilver PTX stents have been used over the past decade to treat patients with PAD.

In the press release, the company stated, "We applaud FDA’s work in the best interest of patients. Cook is pleased that clinicians and patients will continue to have access to important technologies like Zilver PTX. We will continue to collaborate with FDA, clinicians, industry partners, and medical societies to provide the data needed to make informed decisions on treatment options."

Questions about Zilver PTX can be addressed to the company at zilverptx@cookmedical.com and a member of Cook’s team will respond within 24 hours.

All articles from Endovascular Today's continuing coverage of the paclitaxel safety data review are available online here.