Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device.
This “smaller, thinner” new generation platform allows for a 15 percent size reduction and 29 percent fewer components with no compromise in longevity or clinical features the previous DX iteration, according to a press release. The Ilesto DX allows physicians to perform atrial sensing and monitoring with only one-lead, as opposed to the more typical dual-chamber devices. The company claims it is the first device to use only one specialized defibrillator lead to provide full atrial diagnostic info.
The device can also be used in tandem with the company’s remote home monitoring device.
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“Demand for the DX System has led us to prioritize Ilesto DX as the first device launched as part of the new Ilesto family,” Paul Woodstock, executive vice president of sales and marketing at Biotronik, said in the release. “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 percent of de novo implants, and with the launch of Ilesto, we expect this number to increase.”