BIOTRONIK received FDA regulatory approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series of devices.
The flagship device in the series, the Ilesto DX with Home Monitoring, allows physicians to receive atrial information and help diagnose fibrillation that would otherwise go unnoticed. It does this with only one lead, compared with competing devices that have to use two leads for the same monitoring. The Ilesto 7 line received EU clearance earlier this year and has since been made available on the European continent.
“In order to meet unprecedented demand for this novel category of device, the Ilesto DX version will be the first ICD we launch within this series,” said [Paul Woodstock, executive vice president of sales and marketing at BIOTRONIK, Inc., USA]. “In a world driven by benefits and risks, single-lead DX systems deliver on both counts. The ability to provide comprehensive atrial diagnostics while reducing potential complications associated with additional leads represents an unrivaled cutting-edge technological advancement.”
BIOTRONIK DX Systems continue to give physicians the ability to remotely follow their patients’ clinical and device statuses daily – anytime, anywhere in the world via the BIOTRONIK Home Monitoring® system. The cellular-based system is the most user-friendly patient monitoring system capable of combining early detection of clinically relevant events with increased workflow efficiency. The system also allows for secure data sharing amongst multiple care teams, a critical capability as practices and hospitals push to improve patient outcomes. The clear differentiators for the BIOTRONIK Home Monitoring® system are one-step setup, daily transmissions requiring no patient interaction and true mobility at no additional cost. These advantages clearly put the BIOTRONIK Home Monitoring® system in a class by itself. The result is very high patient compliance, which is essential for these systems to provide meaningful clinical value.