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Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series

Biotronik Ilesto ICD CRTD David Prutchi PhD www.implantable-device.comBiotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release:

“BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto DX with BIOTRONIK Home Monitoring® certainly delivers. 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. It also enables early detection of atrial arrhythmia with BIOTRONIK Home Monitoring®.

“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 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.”

 

 
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