FDA approves Ilesto 7 ICD/CRT-D series

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The Food and Drug Administration (FDA) has granted approval for Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillator (ICD/CRT-D) series (Biotronik).

“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, 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.”

The Ilesto 7 series is now approved and currently available in most international markets, including the EU and Japan. In CE markets, the Ilesto 7 series is the second generation of Biotronik´s ProMRI technology, which enables patients access to potentially life-saving MR scans.

Biotronik’s Ilesto 7 series, DX System, Home Monitoring and ProMRI will be showcased at Biotronik’s booth (#929) at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions.