Trial success for new DCB device may lead to a shift in the competitive landscape, says GlobalData

As a result of the outcomes of a trial comparing two drug-coated balloon (DCB) devices, in which no statistically significant patency rate difference was found, data and analytics company, GlobalData, has indicated a potential change in the competitive landscape in this market sector.

Drug-coated balloons, also known as drug-eluting balloons, are used as a therapeutic alternative to de novo angioplasty. They work by delivering an antirestenotic drug (one that widens the arteries to prevent restenosis) to the vessel wall once inflation has occurred.

Currently, there are two devices dominating the US market — Bard’s Lutonix, distributed by Boston Scientific and Medtronic’s In.Pact Admiral. This new trial compared a new device from Boston Scientific called Ranger DCB and Medtronic’s In.Pact Admiral, finding no significant difference between the two devices in how they opened up the arteries.

“Boston Scientific’s Ranger DCB could prove to be tough competition once it enters the US market,” highlighted Sheryl Tang, MPH, medical devices analyst at GlobalData. “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 DCB is currently available in several markets outside of the US but the manufacturer is looking at releasing it into the US and Japanese markets by 2020. However, Boston Scientific already has a US distribution agreement in place with Bard, which also manufactures a BCD — it is expected this agreement will come to an end once the Ranger is available to US customers.

“It is understandable that without the support of a larger company, the DCB market will be dominated by Boston Scientific and Medtronic,” continued Tang. “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.”