FDA Approves Biotronik’s Ilesto 7 ICD/CRT-D Series
May 14, 2013 — Biotronik announced the U.S. Food and Drug Administration (FDA) granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The devices are smaller, thinner and lighter than previous systems.
“With this device, physicians can receive atrial information to ensure diagnostic accuracy and identify previously undetected atrial fibrillation. They also receive peace of mind that there is less risk of complications due to the single lead,” said Paul Woodstock, executive vice president of sales and marketing at Biotronik Inc., USA. “Ilesto’s smaller footprint will be more comfortable as well, which may present a win-win solution for patients and physicians alike.”
Biotronik’s DX platform, which combines the benefits of both single- and dual-chamber ICDs, provides atrial information to aid in diagnostic accuracy while reducing the risk of complications associated with an additional atrial lead.
“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 Woodstock. “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 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 a 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 differentiators for the Biotronik Home Monitoring system are one-step setup, daily transmissions requiring no patient interaction and true mobility at no additional cost.
For more information: www.biotronik.com