Cook Medical is touting stellar four-year patient data for its signature Zilver PTX drug-eluting stent, six months after launching a global recall because some of the devices broke from their delivery catheters during implantation.
The FDA later slapped a Class I recall status on Cook's effort to address the situation--its most serious designation reserved for device problems that can cause injury or death. With that in mind, the new clinical data could go a long way toward restoring positive buzz around the product and reassuring regulators.
In Cook's trial involving 479 patients, the company found a 75% primary patency (opening of the arteries) in the superficial femoral artery at four years. That compares to a patency rate of just under 58% over the same period for patients who just used a bare metal stent. What's more, more than 83% of patients treated with Zilver PTZ didn't need revascularization after four years, versus 69.4% of patients treated with angioplasty or bare metal stent. The trial was a multicenter, prospective, randomized study meant to evaluate Zilver PTX as a treatment for peripheral artery disease in the superficial femoral artery.
"Cook's commitment to providing clinical evidence of the efficacy of drug-eluting devices in the peripheral vessels is unmatched," Rob Lyles, a Cook vice president and head of the company's peripheral intervention clinical division, said in a statement. "With this new data showing lasting patency at four years, we're confident our Zilver PTX stent offers [peripheral artery disease] patients a lasting solution."
The data and Cook's promotion of the results may help counter perceptions of the problems Zilver PTX has faced with the FDA. Cook won approval of Zilver PTX in November to great fanfare, considering it was the first drug-eluting stent cleared to treat peripheral artery disease. But the recall followed in April, and in May, the FDA designed it Class I.
Cook assured the public that the stent itself is safe, so patients already implanted with the device were not affected by the recall. Rather, Cook explained, the problem came from an internal component of the delivery catheter. Cook noted at the time it had received 13 reports that the delivery system had failed, resulting in two adverse events. A patient died during a Zilver PTX procedure, but Cook said there was no indication that the fatality was linked to the delivery system problem.
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