Cardiovascular company Biotronik Inc. has received U.S. Food and Drug Administration (FDA) approval for its Ilesto family of implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D).
Soon after the FDA OK, the company launched its next-generation technology platform, the Ilesto DX.
Ilesto DX offers the established benefits of the firm's existing DX System product line in a thinner and smaller device. The new platform is a 15 percent size reduction with 29 percent fewer components without compromising longevity or clinical features, according to the company.
“Demand for the DX System has led us to prioritize 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 toward quality outcomes and the right technology for the patient. We have already captured more than 10 percent of de novo implants, and with the launch of Ilesto we expect this number to increase.”
Company officials claim the DX technology is based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal. According to the company, the Ilesto DX System is the first defibrillator equipped to provide full atrial diagnostic information with just one specialized defibrillator lead. For conventional ICD systems, providing atrial diagnostic capabilities means placing two wires (leads) in the heart, which can increase the likelihood of complications. The second alternative, a typical single-chamber (single-lead) ICD, has no sensing capability in the atrium and is therefore less equipped to detect silent high atrial rates that may cause stroke and inappropriate shocks.
“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, M.D., cardiologist at the University Medical Center of Southern Nevada in Las Vegas. “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, M.D., clinical associate professor at the Carver School of Medicine at University of Iowa in Iowa City. “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.”
Biotronik is headquartered in Berlin, Germany, and has a global workforce of more than 5,600 employees. U.S. headquarters are in Lake Oswego, Ore.