FDA approves Biotronik’s “smaller, thinner” heart rhythm implants

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German medical device maker Biotronik today touted FDA approval for its Ilesto 7 line of next-generation implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

The devices are smaller, thinner and lighter and the new Ilesto DX allows physicians to monitor atrial information and possibly diagnose previously undetected instance of atrial fibrillation.

Biotronik is planning an immediate launch of the Ilesto DX in respond to "unprecedented demand for this novel category of device," the company reported.

"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," according to the press release. "It also enables early detection of atrial arrhythmia with Biotronik Home Monitoring."

"In a world driven by benefits and risks, single-lead DX systems deliver on both counts," sales & marketing executive vice president Paul Woodstock said in prepared remarks. "The ability to provide comprehensive atrial diagnostics while reducing potential complications associated with additional leads represents an unrivaled cutting-edge technological advancement."

In February of this year Biotronik also won CE Mark approval in the European Union for the next-generation Ilesto 7 series, with ProMRI technology that allows the devices to safely withstand MRI scanning.

Earlier this year Biotronik won European regulatory approval for its MRI-safe Iforia defibrillator. The medical device company said the Iforia is the world’s 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.

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