Competitive PressureCompetitive dynamics are intensifying for Boston's Emblem S-ICD, which is now facing competition for the first time from Medtronic’s Aurora EV-ICD.
Product Portfolio GapsBoston still has gaps and weaknesses in its vascular portfolio, including areas like aortic and cutting balloons, where many products are commoditized with equally good alternatives available.
Regulatory And Approval ChallengesBoston did not submit an NTAP application for Farapulse as the company did not expect to have secured FDA approval in time for the NTAP filing.