Boston Scientific has obtained approval from the US Food and Drug Administration (FDA) for its Dynagen Mini and Inogen Mini implantable cardioverter-defibrillators (ICDs), and Dynagen X4 and Inogen X4 cardiac resynchronization therapy defibrillators (CRT-Ds).
Offering 70% more pacing options, the X4 line of quadripolar CRT-Ds addresses high capture thresholds and phrenic nerve stimulation effectively.
The X4 line of quadripolar CRT-Ds feature largest battery capacity in the industry, the company claims.
Boston Scientific’s newly approved devices come with a six-year CRT-D warranty and have industry-leading projected longevity.
Designed for patient comfort, the ICDs in the Mini family are the world’s smallest and thinnest devices.
Compared to competitive devices from other manufacturers, the Mini ICDs are approximately 24% thinner and their dimensions are up to 20% smaller by volume.
Boston Scientific executive vice president and Rhythm Management division president Joe Fitzgerald noted that with the new devices and the company’s current line of long-lasting ICDs and CRT-Ds, including the world’s only subcutaneous ICD, the company believes that it offers the very best range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronization therapy.
"Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients," Fitzgerald added.
Image: Boston Scientific’s Corporate Headquarters in Natick, Massachusetts. Photo: Courtesy of Boston Scientific Corporation