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


April 24, 2014

April 24, 2014 — Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) approval for its latest generation of defibrillators and heart failure devices. The newly approved 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.

"The tiny size of the Mini ICD provides a real benefit to some patients, in particular those with a smaller frame," said Hans-Joachim Trappe, M.D., University Marien Hospital Herne, Hospital of Ruhr-University, Bochum, Germany. "The Mini ICD not only improves patient comfort, but also provides these patients with innovative technology to help treat life-threatening arrhythmias of the heart."

"With these new devices and our current line of long-lasting ICDs and CRT-Ds, including the world's only subcutaneous ICD, we believe we offer the very best range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronization therapy," said Joe Fitzgerald, executive vice president and president for the Rhythm Management division of Boston Scientific. "Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients."

For more information: www.bostonscientific.com