Cook Medical is shipping its Zilver PTX drug-eluting peripheral stent to medical centres in the USA, Japan, Europe and other major markets again. The shipments follow a brief period of unavailability due to a voluntary recall by Cook related to an issue with the stent’s delivery catheter that has been resolved.
“This is great news for physicians treating peripheral arterial disease in the superficial femoral artery because it means the only drug-eluting stent approved to treat this condition is available again in the USA, Japan, Europe and other key markets,” explained Rob Lyles, vice president and global leader of Cook’s Peripheral Intervention clinical division. “Clinical trials have shown that compared to bare metal stents, Zilver PTX provides longer-lasting results and cuts the need for repeat procedures in half.”
In 2009, Zilver PTX became the first drug-eluting peripheral stent in the world approved for peripheral arterial disease in the superficial femoral artery when it was introduced to European physicians following CE mark approval. The device, which received a unanimous recommendation for approval from the circulatory device review panel of the US Food and Drug Administration (FDA), was approved USA sale in November 2012. In April 2012, it became the only drug-eluting peripheral stent approved for sale in Japan.
Several thousand peripheral arterial disease patients in Europe, the USA, Japan and more than 50 other markets around the world have been treated with the Zilver PTX stent. Cook’s device features a self-expanding stent of shape memory nitinol coated with the anti-cell proliferation drug paclitaxel. In more than three years of clinical study compared to bare metal stents, Zilver PTX has been shown to have a proven drug effect, reduced reintervention rates, and longer-lasting vessel patency.
The Lancet reported last week that peripheral arterial disease has reached epidemic levels in the developed world, with 38 million new cases reported in the last 10 years.
“More than ever, doctors need the best tools possible to treat this disease,” Lyles noted. “As the only company to produce drug eluting stent technology for peripheral arterial disease in the superficial femoral artery, we are proud to help address that urgent need.”
The device is being shipped, Lyles added, following regulatory approvals of the steps Cook has taken to address the issue of catheter tip separation that prompted Cook’s voluntary recall.