Boston Scientific enters the US peripheral drug-eluting stent market

Boston Scientific’s recent FDA approval for the Eluvia Stent System may disrupt Cook Medical’s position in the US peripheral stents market, with Cook expected to face stronger competition trying to maintain a larger share of the market in the future, says GlobalData, a leading data and analytics company.

FDA approval was granted to Boston Scientific after the announcement of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, the news is anticipated to disrupt Cook Medical’s current monopoly over the US market.

Jeff Mirviss, senior vice president and president, Peripheral Interventions, Boston Scientific said: “Over the past decade, we’ve seen significant advancements in the treatment of peripheral artery disease, yet clinical and economic outcomes still present an opportunity for innovation and to improve patient care.”

Mirviss added: “With the FDA’s approval of the Eluvia stent, we can now bring the transformative power of sustained drug release to clinicians and the millions of patients suffering from this terrible disease.”

Sheryl Tang, senior medical devices analyst at GlobalData, comments: “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 (drug eluding stent) manufacturer on the market. Boston Scientific entered the market in 2016 when the Eluvia became CE marked.

Tang continued: “We predict 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 maintaining a significant portion of the market in the future.”

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).