Cook’s Zilver PTX Returns to Market and Gains Additional CMS Reimbursement
August 7, 2013—Cook Medical (Indianapolis, IN) has resumed shipment of its Zilver PTX paclitaxel-eluting peripheral stent after addressing a delivery catheter issue that led the company to issue a voluntary recall of the platform earlier this year. The device is once again available in the United States, Japan, Europe, and other major markets.
While discussing the resumption of shipment for Zilver PTX with Endovascular Today, Rob Lyles, Vice President and Global Leader of Cook Medical’s Peripheral Intervention clinical division, also stated that on August 2, the US Centers for Medicare & Medicaid Services (CMS) issued its 2014 Final Rule, which included that there will be a new technology add-on payment for Zilver PTX in fiscal year 2014. This rule will take effect on October 1, 2013.
“It is an exciting piece of news and a nice endorsement of the technology, quite frankly, because it means that upon a very thorough review of the literature, that the technology is effective enough, creating substantial clinical improvement compared to existing technology, that it’s worthy of additional reimbursement,” commented Mr. Lyles.
Under the new technology add-on payment, Mr. Lyles indicated that hospitals will be eligible for up to $1,705 of additional reimbursement for Zilver PTX inpatient procedures.
Regarding the issues that led to the voluntary recall and subsequent re-release of Zilver PTX, Mr. Lyles described that Cook Medical had received a few reports of difficulties in cases in Japan, and as the company investigated these, they found that a raw material in a component of the platform’s delivery catheter was out of specification. Cook Medical worked with the outside vendor who supplied the affected component to successfully address the issue, then began presenting all related information and the revised device to regulatory officials in every major market around the world.
“[We] went through in extreme detail everything that we had discovered and everything that we had done to remedy the situation,” said Mr. Lyles. “In all cases, they were thoroughly satisfied and gave us the clearance to return to market.”
The Zilver PTX platform’s Instructions For Use have also been revised to emphasize the importance of using a .035-inch wire guide. Mr. Lyles indicated that in two cases in which there were difficulties with the delivery catheter, .035-inch wires were not used.
Zilver PTX first became available in the European market in 2009 following CE Mark clearance, received approval in Japan in April 2012, and the United States in November 2012. With the device once again available in global markets and production ramping up, Mr. Lyles anticipates a broad and rigorous rollout in the coming months.