Indiana's Cook Medical is marketing its Zilver PTX drug-eluting stent in Australia, expanding the base of a device already available in more than 50 countries.
Zilver PTX is designed to treat peripheral artery disease in the femoral artery by stenting and eluting paclitaxel to prevent reclosure. The family-owned company believes getting the device on the Australian market will help boost revenues and adoption.
"Many physicians now are convinced drug elution is the future of treating lesions in the leg arteries, and our Australian Zilver PTX launch is an important step in Cook's efforts to bring this advanced treatment to patients and physicians around the world," Vice President Rob Lyles said in a statement.
The device got its CE mark in 2009 and has been available in Europe since then, but it has yet to get FDA approval. An agency panel recommended Zilver back in 2011, but it remains under review for U.S. marketing.
Further approvals around the world could bolster Cook's case to the FDA and there's certainly money to be made: Market research firm Technavio has projected that the market for peripheral vascular devices could reach $5.6 billion by 2014.
- read Cook's release