FDA gives thumbs up to mini ICDs
The FDA approved the latest generation of Boston Scientific’s implantable cardiac devices.
Natick, Mass.-based Boston Scientific received the go-ahead to market devices that include its Dynagen Mini and Inogen Mini implantable cardioverter-defibrillators (ICDs) and Dynagen X4 and Inogen X4 cardiac resynchronization therapy-defibrillators (CRT-Ds). The company claims the Mini devices are 20 percent smaller by volume and 24 percent thinner than other devices. The X4 line of devices includes a six-year CRT-D warranty.
The devices are approved for patients with heart failure and those at risk of sudden cardiac death.