US-based medical device company Cook Medical has enrolled the first patient in the study of Zilver PTX Drug Eluting Peripheral Stent in China.
Principal investigator Professor Peng Liu has undertaken the case at the China-Japan Friendship Hospital in Beijing.
Peng Liu said that the product represents the latest drug technology in the peripheral vascular system.
"We are looking forward to bringing this new technology to Chinese patients to overcome the troublesome restenosis problem," Liu added.
The study, which is said to be first of its kind in China, will be conducted at around 20 clinical sites with enrollment of 175 patients with one-year followup.
It includes evaluating the efficiency of the Zilver PTX stent to treat peripheral artery disease (PAD) in the superficial femoral artery in Chinese patients.
The data collected from the Chinese patient will be compared to patient results shown in Cook’s global randomized clinical study of the device.
The company will provide the collected data to CFDA in support of commercial registration of Zilver PTX in China.
Cook Medical vice president and global leader of company’s Peripheral Intervention clinical division Mark Breedlove said the company convinced drug elution is the future of treating PAD, based on the evidence to date.
"This milestone moves Cook one step closer to bringing this remarkable technology to Chinese physicians and the patients they treat," Breedlove added.
Cook Medical noted that the study is a pre-market requirement of the China Food and Drug Administration (CFDA).
Image: Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent enters clinical trials in China. Photo: courtesy of Business Wire.