Technology | May 14, 2013

FDA Approves Biotronik’s Ilesto 7 ICD/CRT-D Series

Device offers smaller, thinner ICD/CRT-D, including the DX platform


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


Related Content

News | Implantable Cardioverter Defibrillator (ICD)

Sept. 2, 2024 – Medtronic recently shared long-term results from the global Extravascular Implantable Cardioverter ...

Home September 05, 2024
Home
News | Implantable Cardioverter Defibrillator (ICD)

February 12, 2024 — BIOTRONIK, a leader in implantable medical device technology, announced today they will solely ...

Home February 12, 2024
Home
News | Implantable Cardioverter Defibrillator (ICD)

October 23, 2023 — Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug ...

Home October 23, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 28, 2023 — Is the routine implantation of an implantable cardioverter defibrillator (ICD) in myocardial ...

Home August 28, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 28, 2023 — Upgrade to cardiac resynchronization therapy with a defibrillator (CRT-D) reduces morbidity and ...

Home August 28, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

July 18, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Medtronic ICDs and CRT-Ds ...

Home July 18, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

March 7, 2023 — Ninety-five percent of athletes with a diagnosed and treated genetic heart disease experienced no ...

Home March 07, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

February 17, 2023 — Medtronic plc has received CE (Conformité Européenne) Mark for the Aurora EV-ICD MRI SureScan ...

Home February 17, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 29, 2022 — Medtronic plc announced that its investigational EV ICD System – a first-of-its-kind defibrillator ...

Home August 29, 2022
Home
Subscribe Now