Cook Medical has gained the first ever Japanese market approval for a drug-eluting peripheral stent with the news that its Zilver® PTX® device has gained PMDA clearance. Now for the first time Japanese patients will have access to this type of combination therapy to peripheral artery disease (PAD). Furthermore the device, indicated for treating PAD in the superficial femoral artery (SFA), is the first stent available in Japan approved for use in the SFA.
Last October we reported that the company was making progress towards US FDA clearance for the device following news that its advisory panel had unanimously voted in its favour. That item can be found here. Zilver PTX received CE Mark approval in August 2009 and is now available in more than 45 countries. It offers physicians treating PAD in the SFA the combination of mechanical support via stenting with the drug paclitaxel to reduce the risk of restenosis.
According to a company press release the approval was founded on a cooperative, multinational regulatory effort, a clinical trial for this product having been carried out by Cook in Japan, the United States and Germany, with data from the trials being used to support regulatory submissions for Zilver PTX in Japan, the U.S. and Europe.
“The Zilver PTX peripheral stent represents progress in treating PAD, and the Japanese government should be proud of the commitment it has shown to patients with this timely approval,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “Drug elution has come to the periphery for a reason. Clinical trials show that Zilver PTX has better long-term patency outcomes than bare-metal stents.”
Mitsuo Asami, vice president of Cook Japan and leader of Cook Japan’s Peripheral Intervention division added, “We are proud that this approval will bring Zilver PTX to Japanese physicians and patients. We intend to continue to support all medical practitioners by providing safe and minimally invasive treatment options for PAD.”
Source: Cook Medical