Cook's Zilver PTX Stent Returns to the Marketplace
Published date : 12 August 2013
Article date : 12 August 2013
Angioplasty.org reports that Cook Medical has resumed distribution of the Zilver PTX drug-eluting stent designed for use in treating peripheral artery disease. The manufacturer has stated that the FDA has approved their revision of the catheter tip separation issue that lead to Cook's voluntary recall in April 2013. This was followed by an FDA Class I recall in May.
The the only drug-eluting stent approved to treat peripheral artery disease, the Zilver PTX is available in the US, Japan, Europe and other markets. Cook say that clinical trials have shown that compared to bare metal stents, the device provides more prolonged results and can reduce repeat procedures by 50%.
Read the full article, which includes a press release from Cook Medical, here.
Source: Anioplasty.org