FDA Clears Boston Scientific’s New Defibrillators and Heart Failure Devices


April 24, 2014

Boston Scientific Corp. received U.S. Food and Drug Administration (FDA) approval for its latest generation of defibrillators and heart failure devices in April 2014. The devices include the Dynagen Mini and Inogen Mini ICDs (implantable cardioverter defibrillators), as well as the Dynagen X4 and Inogen X4 CRT-Ds (cardiac resynchronization therapy devices).

The X4 line of quadripolar CRT-Ds offers 70 percent more pacing options to address high capture thresholds and phrenic nerve stimulation effectively, along with a large battery capacity and a six-year warranty.

Extending the Boston Scientific portfolio of defibrillators, the ICDs in the Mini family are the world's smallest and thinnest devices, according to Boston Scientific, and are designed for patient comfort. The small dimensions of the Mini ICD are up to 20 percent smaller by volume and up to 24 percent thinner than competitive devices from other manufacturers.

For more information: www.bostonscientific.com