Following what it calls a “brief period of unavailability following a voluntary recall, Cook Medical is again shipping its Zilver® PTX® Drug-Eluting Peripheral Stent to medical centers in the U.S., Japan, Europe and other major markets. This follows a few months of unavailability due to a voluntary recall by Cook related to an issue with the stent’s delivery catheter that has been resolved.
In 2009, Zilver PTX became the first drug-eluting peripheral stent in the world approved for peripheral artery disease (PAD) in the superficial femoral artery (SFA) when it was introduced to European physicians following CE Mark approval. The device was approved U.S. sale in November 2012 and in April 2012, it became the only drug-eluting peripheral stent approved for sale in Japan.
Back in April 2013 Cook initiated a voluntary recall following a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Because of the serious consequences in cases where inner deliver catheter breakage occurs the action was subsequently made the subject of a Class I recall, the FDA’s highest category of recall notice, as we reported at the time.
Anyway, the device is again being shipped, following regulatory approvals of the steps Cook has taken to address the issue of catheter tip separation, which will no doubt be a relief to Cook and well received by physicians for whom the device has delivered reduced reintervention rates, and longer-lasting vessel patency.
“This is great news for physicians treating peripheral artery disease in the superficial femoral artery because it means the only drug-eluting stent approved to treat this condition is available again in the U.S., 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.”
“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 PAD in the SFA, we’re proud to help address that urgent need.”
Source: Cook Medical