Biotronik Releases New ICD

The U.S. Food and Drug Administration has approved cardiovascular device company Biotronik Inc.’s Ilesto 7 implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The devices are being touted as smaller, thinner and lighter without compromising clinical capabilities. The first device to be released from the series will be the Ilesto DX.

“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,” said Paul Woodstock, executive vice president of sales and marketing at Biotronik U.S. “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. 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 combines single- and dual-chamber ICDs and provides atrial information to aid in diagnostic accuracy while reducing the risk of complications associated with an additional atrial lead, claims the company. Biotronik home monitoring also reportedly enables early detection of atrial arrhythmia.

“In a world driven by benefits and risks, single-lead DX systems deliver on both counts,” added Woodstock on why the Ilesto DX was selected as the first release from the series. “The ability to provide comprehensive atrial diagnostics while reducing potential complications associated with additional leads represents an unrivaled cutting-edge technological advancement.”

The home monitoring system is designed to allow physicians to access and follow their patients clinical and device status daily from anywhere in the world. The monitoring system operates with cellular phone technology, and according to the company, enables secure data sharing amongst multiple care teams, a critical capability as practices and hospitals push to improve patient outcomes. The daily transmissions the system is designed to give means that there is a lot less need for patient/physician interaction, and adds more mobility possibilities. The hope is that this will result in more patient compliance, which is essential for these systems to provide meaningful clinical value.

The Ilesto 7 series currently is available in most international markets, including the European Union and Japan. In CE markets, the Ilesto 7 series is the second generation of Biotronik’s ProMRI technology, which enables patients access to magnetic resonance scans.

Biotronik is headquartered in Berlin, Germany, with U.S. offices in Lake Oswego, Ore.