Fierce Biotech May 20, 2024
A six-month trial showed that Boston Scientific’s pairing of modular, wireless implants for managing discordant cardiac rhythms—and correcting dangerous ones—could be a successful approach, and the devicemaker has its heart set on an FDA approval for the system in 2025.
The company linked its leadless Empower pacemaker with its Emblem subcutaneous implanted defibrillator. The approach allows one device to keep the heart from beating too fast or too slow, while the other stands by to deliver a shock to interrupt potentially fatal arrhythmias.
The Emblem’s design aims to avoid some of the long-term complications seen with traditional implantable cardioverter defibrillators (ICDs) that have generators wired into the heart through the veins, such as infections; its less invasive route places leads...
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