Boston Scientific has received 510(k) clearance from FDA to sell its LUX-Dx insertable cardiac monitor system for use in the detection of arrhythmias.
The medical device giant said its system is the first ICM to enable physicians to adjust the device’s event detection settings remotely.
- Boston Scientific plans to use that feature to help differentiate its device from ICMs sold by Abbott and Medtronic in a market it values at around $750 million.
Physicians implant ICMs such as Abbott’s Confirm Rx and Medtronic’s Reveal LINQ system to collect heart rhythm data and thereby spot signs of conditions including atrial fibrillation, cryptogenic stroke and syncope.
Boston Scientific identified ICM as a $750 million market adjacent to its existing business, creating an opportunity to add a new growth driver while leveraging existing commercial infrastructure. That thinking led to the development of LUX-Dx, a device that Boston Scientific claimed demonstrated a “significant improvement” over existing ICM atrial fibrillation algorithms in early assessments.
Now, Boston Scientific has secured the 510(k) clearance it needs to challenge Abbott and Medtronic for the ICM market. The company has ceded a sizable head start to Abbott and Medtronic, which have 510(k) clearances dating back to 2017 and 2014, respectively, but contends the features of LUX-Dx set it apart from its more established rivals.
In previous statements, Boston Scientific has highlighted the “competitive device characteristics and implant experience” of LUX-Dx and identified the “interactive mobile patient experience and remote data management system” as a differentiator. Boston Scientific expanded on those claimed benefits in a statement to disclose the 510(k) clearance.
Patients who receive the implant will also be given a mobile device preloaded with an app that links to LUX-Dx via Bluetooth. The app sends information collected by the implant to a data management system, either on a daily basis or as needed. Physicians can also set the system up to issue alerts when an arrhythmia is detected. Boston Scientific has taken steps to reduce false positives.
The company will immediately start a limited rollout of LUX-Dx in the U.S. A full launch is planned for later this year, suggesting it will be 2021, at the earliest, before the ICM starts to bring in meaningful sales for Boston Scientific.
The device will fit into Boston Scientific’s small, growing electrophysiology business. The division generated sales of $329 million in 2019, up 7% over the prior year. Going into the year, LUX-Dx was one of seven products Boston Scientific aimed to introduce across its cardiac rhythm management and electrophysiology units in 2020.
Since then, the units have been negatively affected by COVID-19. Analysts at SVB Leerink expect the recovery to be fairly slow, noting that a high-volume electrophysiologist believes Boston Scientific’s Watchman device will be “further down the recovery curve, driven by the non-urgent elective nature of the procedure and the decline in echocardiograms during COVID.”
In the longer term, LUX-Dx could help the unit bounce back. Boston Scientific sees opportunities to use the platform that underpins LUX-Dx in the management of other diseases, enabling it to execute its plans to build a diagnostic portfolio.
The LUX-Dx 510(k) clearance came days after the National Institute for Health and Care Excellence backed the use of Boston Scientific’s Rezum in the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia. The decision sets Boston Scientific up to challenge Teleflex, the maker of UroLift, for the U.K. market.