Medtronic’s recent FDA-approved Aurora Extravascular Implantable Cardioverter Defibrillator (EV-ICD) is poised to revolutionise the cardiac device market. This device, which places leads outside both the heart and vascular system, offers a significant innovation by minimising risks traditionally associated with defibrillator implants, such as lead fractures and vascular damage. The Aurora EV-ICD’s design allows it to provide defibrillation and pacing, making it a versatile option for patients requiring both treatments, a capability that sets it apart from other systems on the market.
Boston Scientific has long been a leader in the subcutaneous ICD (S-ICD) space with its Emblem S-ICD, which is specifically designed for patients who need defibrillation but do not require pacing. However, Medtronic’s Aurora EV-ICD presents a formidable alternative. Its minimally invasive approach and dual-functionality could reshape the competitive landscape. Since the Aurora received both FDA and CE mark approval in 2023, Boston Scientific has felt the impact, with Emblem S-ICD revenues declining by more than 20% in Q1 2024 in comparison to previous years’ Q1s. This trend underscores the growing appeal of Medtronic’s new technology.
The Aurora EV-ICD’s ability to offer pacing is a critical differentiator. While the Emblem S-ICD is praised for its simplicity and effectiveness in delivering life-saving defibrillation, it lacks pacing support, which limits its use to a narrower patient population. As more clinicians and patients become aware of the Aurora’s broader clinical utility, the shift in market preference could accelerate, positioning Medtronic to capture significant market share.
The key question for the future remains whether EV-ICDs, similar to the Aurora, could fully replace S-ICDs. While the Aurora offers numerous benefits, such as fewer complications and increased functionality, factors like cost, reimbursement challenges, and individual patient needs will play a crucial role in determining if EV-ICDs will fully displace traditional subcutaneous systems.
