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Boston Scientific recently received FDA approval for the Eluvia Stent System, after the announcement of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, disrupting Cook Medical’s current monopoly over the US market.

Peripheral artery disease remains one of the most prevalent diseases worldwide, affecting over 200 million people in 2010, and has continued to increase since. Advancements from surgical interventions have led to the development of minimally invasive procedures, such as percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS), which are considered the golden standard of treatment for many patients, including those considered too high risk for surgery. However, both PTA balloons and BMS devices are shown to have high rates of in-stent restenosis, a problem that drug-eluting stents (DES) were designed to overcome.

The US market is currently dominated by Cook Medical’s Zilver PTX drug-eluting stent system, which was CE marked in 2009 and received FDA approval in 2012. Over the years, Cook has had the opportunity to gain a solid share in the peripheral stents market as the only DES manufacturer on the market. Boston Scientific entered the market in 2016 when the Eluvia became CE marked.

GlobalData predicts that since Boston Scientific’s DES is still new in the market, it will take some time before a portion of the market is taken from Cook. However, with Boston Scientific’s large product portfolio and established presence among many other medical device markets, the Zilver PTX will need to be proven to be superior over the Eluvia, or Cook will face tough competition in trying to maintain a larger share of the market in the future.

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By GlobalData