Biotronik, a German medical device company, has launched its next-generation technology platform, Ilesto DX, following FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillators (ICD/CRT-D).

The new electromechanical platform is a 15% smaller in size and requires 29% fewer components with no compromise in longevity or clinical features.

It is reportedly the first defibrillator system to use only one specialised defibrillator lead to provide full atrial diagnostic information.

The FDA approved Ilesto line of thinner, smaller cardiac implants allows physicians to monitor atrial information and possibly diagnose previously undetected instances of atrial fibrillation.

Biotronik USA executive vice-president of sales and marketing Paul Woodstock said demand for the DX system has led the company to prioritise Ilesto DX as the first device launched as part of the new Ilesto family.

“We have already captured more than 10% of de novo implants, and with the launch of Ilesto, we expect this number to increase,” Woodstock said.

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The Ilesto DX allows physicians to perform atrial sensing and monitoring with only one-lead, as opposed to the more typical dual-chamber devices.

“We have already captured more than 10% of de novo implants, and with the launch of Ilesto, we expect this number to increase.”

The system’s sensing capabilities in combination with Biotronik Home Monitoring allows rapid and continuous monitoring of the device performance.

Biotronik USA vice-president of marketing and communications Rex Richmond said through advanced design and the use of robotic manufacturing, Biotronik has developed a highly automated production process for the electronic module.

“The Ilesto platform is the latest example of BIOTRONIK’s guiding principle of engineering excellence into all of our products,” Richmond said.

The DX System helps overcome deficiencies associated with the conventional ICD systems and helps cardiologists obtain better patient outcomes.

According to GlobalData estimates, Implantable Cardioverter Defibrillators market in the US was valued at $1.94bn in 2012 and is expected to grow at a CAGR of 2.5% to reach $2.3bn by 2019.

Image: Ilesto 7 VR-T DX. Photo: courtesy of Biotronik SE & Co.KG.