US-based medical device firm Cook Medical has enrolled the first patient in its clinical trial of Zilver PTX Drug Eluting Peripheral Stent in China.
Zilver PTX is indicated to treat symptomatic vascular disease of the above-the-knee femoropopliteal arteries having a reference vessel diameter from 4mm to 9mm.
Principal investigator Dr Peng Liu has undertaken the first case in the trial at the China-Japan Friendship Hospital in Beijing.
Dr Liu said: "It’s great to have enrolled the first case of Zilver PTX China clinical trial by our centre.
"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."
The clinical trial is being conducted at approximately 20 clinical sites and will enrol around 175 patients with one-year follow-up.
Claimed to be the first of its kind in China, the trial is designed to evaluate the efficiency of the Zilver PTX stent for the treatment of peripheral artery disease (PAD) in the superficial femoral artery in Chinese patients.
Data secured from the Chinese patient will be compared to patient results shown in the company’s global randomised clinical trial of the Zilver PTX.
The company will submit the collected data to the China Food and Drug Administration (CFDA) in support of commercial registration of the device in China.
Cook Peripheral Intervention clinical division vice-president and global leader Mark Breedlove said: "Based on the evidence to date, we’re convinced drug elution is the future of treating PAD.
"This milestone moves Cook one step closer to bringing this remarkable technology to Chinese physicians and the patients they treat.
"We look forward to concluding this study quickly and making a timely submission to CFDA."
So far, Zilver PTX has been studied clinically in more than 2,200 patients worldwide and is approved for commercial sale in the US, Japan, Europe, Canada, Australia, Brazil, India and other markets.
Image: Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent enters clinical trials in China. Photo: courtesy of Business Wire / Cook Medical.
