FDA approves Biotronik’s Ilesto ICD and CRT-D devices


On 1 October, Biotronik announced the Food and Drug Administration (FDA) approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillators (ICD/CRT-D). After FDA approval, Biotronik also announced the launch of Ilesto DX.

According to a company release, the DX technology allows for atrial sensing with just one lead, feature that may help to reduce the likelihood of complications currently perceived with the placement of two leads with conventional ICD systems.

“In the past, I preferred dual-chamber devices because I value the atrial information. With the DX, I no longer have to make that choice,” said Robert Wesley, cardiologist at the University Medical Center of Southern Nevada, Las Vegas, USA. “The DX system represents a solution to the dilemma of whether to choose a dual-chamber or single-chamber defibrillator system, eliminating complications related to the placing of a second lead. This is why the DX system has become a significant part of my ICD mix.”

“The system’s sensing capabilities in combination with Biotronik Home Monitoring allows me to rapidly and continuously monitor how well the device is performing – which offers reassurance to both me and the patient, ” said Alexander Mazur, clinical associate professor at the Carver School of Medicine at University of Iowa, Iowa City, USA. “In a more recent case, a patient was experiencing a fast ventricular rate caused by atrial arrhythmia. We were alerted of the episode through Home Monitoring and the atrial information from the DX system helped to avert inappropriate therapy for the patient.”

“Demand for the DX system has led us to prioritise Ilesto DX as the first device launched as part of the new Ilesto family,” said Paul Woodstock, executive vice president of sales and marketing at Biotronik, USA. “The rapid adoption of the DX system is a clear example of the market shift towards quality outcomes and the right technology for the patient. We have already captured more than 10% of de novo implants, and with the launch of Ilesto, we expect this number to increase.”