Cook Medical said it enrolled the 1st patient in a 1st-of-its-kind clinical trial in China for its Zilver PTX drug-eluting peripheral stent as it looks to win approval for the device in the People’s Republic.
The trial will compare results from the Chinese patients with peripheral artery disease of the superficial femoral artery with data from Cook’s global randomized clinical study, according to a press release.
Cook won FDA approval for the Zilver PTX in November 2012, but pulled the device in April 2013 after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. Zilver was back on the market 3 months later after the problems were corrected. In September 2013 the Centers for Medicare & Medicaid Services added new reimbursement coverage for the device.
"Based on the evidence to date, we’re convinced drug elution is the future of treating PAD. This milestone moves Cook 1 step closer to bringing this remarkable technology to Chinese physicians and the patients they treat," Mark Breedlove, vice president & global leader of Cook’s peripheral intervention division, said in prepared remarks. "We look forward to concluding this study quickly and making a timely submission to [the China Food & Drug Administration]."
The 175-patient Chinese study is slated for up to 20 clinical sites and includes 1 year of follow-up, according to a press release. Six patients at 2 sites are now enrolled, according to the release.