FDA approves next-generation Boston Scientific ICDs, CRT-Ds
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Boston Scientific announced that it has received FDA approval for its newest generation of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
The devices covered in the approval include the Dynagen Mini and Inogen Mini ICDs and the Dynagen X4 and Inogen X4 CRT-Ds. The Mini ICDs are up to 20% smaller and 24% thinner than other available ICDs, according to a company press release.
The X4 line of quadripolar CRT-Ds offers a large battery capacity and 70% more pacing options to address high capture thresholds and phrenic nerve stimulation effectively, according to the release.
The devices are indicated for patients with HF and/or patients at high risk for sudden cardiac death.