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Drug-eluting balloon trial results indicate positive outlook for Boston Scientific’s entrance into the US market, says GlobalData

In January 2018, Boston Scientific announced results from a first-of-its-kind trial comparing its Ranger drug-coated balloon (DCB) to Medtronic’s In.Pact Admiral DCB, revealing no statistical difference in patency rates between the two balloons. With such promising results, this has the potential to change the competitive landscape in the DCB market, according to GlobalData, a leading data and analytics company.
Peripheral artery disease, characterized by the narrowing of the arteries by plaque built-up, is one of the most prevalent chronic diseases worldwide, increasing the risk of a heart attack, stroke, or amputation of limbs. Drug-coated balloons aim to widen the artery and prevent restenosis that commonly occurs with stent placements.
The current US market is dominated by two devices: Bard’s Lutonix, distributed by Boston Scientific and Medtronic’s In.Pact Admiral. While the Lutonix device was the first FDA-approved DCB, the In.Pact Admiral rapidly gained market share due to better clinical results and Medtronic’s large product portfolio in the medical device industry.
Sheryl Tang, MPH, Medical Devices Analyst at GlobalData, comments: “Boston Scientific’s Ranger DCB could prove to be tough competition once it enters the US market. This device has a lower profile and a lower dose of paclitaxel is coated on the balloon compared to the In.Pact Admiral. The lower dose of paclitaxel will decrease the risk of emboli debris forming, which had previously been found with the higher doses on Medtronic’s device. Furthermore, thinner balloons promote ease of use and cost efficiency.”
The Ranger is currently available in a number of markets outside of the US, and Boston Scientific is looking to release the DCB into the US and Japanese markets by 2020. The arrival of the Ranger has the potential to completely shift the competitive landscape. While Medtronic’s device has gained a large market share in markets across the globe, potential reduced post-procedural complications and advanced features in the Ranger could boost Boston Scientific’s position in the DCB market.
The US market will prove to be slightly more complicated due to the distribution agreement between Boston Scientific and Bard. Following the introduction of the Ranger into the US market, the distribution agreement will likely end, as Boston Scientific will distribute its own DCB.
Tang continues: “It is understandable that without the support of a larger company, the DCB market will be dominated by Boston Scientific and Medtronic. However, the recent acquisition of Bard by Becton Dickinson can help Bard’s Lutonix maintain a decent share of the US market, making the future competitive landscape less predictable.”
Boston Scientific has set its course on gaining a strong foothold in the peripheral vascular space, a large and continuously growing market. Although they will go head-to-head with tough competitors with well-established devices on the market, the company can be expected to quickly gain a strong presence with advancements in technology.