In response to a recent meta-analysis that linked paclitaxel-coated devices to higher mortality rates in peripheral artery disease (PAD) patients, interventional technology developer Cook Medical said that several new studies confirm the safety record of its Zilver PTX paclitaxel-eluting stents.
In research presented this week at the Leipzig Interventional Course (LINC) in Germany, Dr. Michael Dake -- principal investigator for the Zilver PTX randomized controlled trial -- found no increased mortality rates at five years with the use of a Zilver PTX stent versus noncoated stents and balloons. In contrast with the meta-analysis, which didn't include patient-level data, Dake reviewed all patient-level data in the Zilver PTX five-year follow-up of 479 patients, Cook said.
In addition, a recently released five-year postmarket Japanese study showed positive long-term safety and effectiveness outcomes from the use of Zilver PTX stents in real-world patients, according to the firm.
