Biotronik recently announced the FDA approval of one of their newest implantable cardioverter-defibrillator (ICD) devices, the Ilesto DX. Like their previously released device, the Lumax DX, the Ilesto DX allows for dual chamber sensing with the utilization of a single lead. I recently had the chance to connect with Rex Richmond, Biotronik’s Vice President of Marketing and Communications, who took some time out of his busy schedule to answer a few questions about their new device
1.) Is there anything in particular that distinguishes the Ilesto DX from the Lumax DX ?
Yes, Ilesto is built on a completely new electromechanical platform that reduces component count, reduces the overall volume requirements for the electronics and improves the efficiency of the device. The result is a thinner, lighter, device with lower overall volume. It’s also important to note that Ilesto is built using state of the art robotic manufacturing processes designed to eliminate human touch. The goal is to reduce the chance for errors introduced via human interaction. Ilesto is designed to give physicians an important option that has not previously been available. Simply put, it provides atrial diagnostics without the introduction of additional hardware. The result is reduced procedure time, lower physician exposure to unnecessary fluoro exposure, and the avoidance of uneccessary risk in terms of infection and hardware failure for the patient.
2.) Does the FDA approval on the Ilesto restrict its use to a particular patient population/disease process?
Ilesto is indicated according to the guidelines previously established for ICD therapy. There are no additional restrictions.
3.) Are there any contraindications for the Ilesto – besides the need for atrial pacing?
No, and actually, although this device is not designed to provide atrial pacing, it is not specified as a FDA required contraindication.
4.) Do the two devices (Lumax DX & Ilesto DX) utilize the same leads, or has there been, or is there going to be a more advanced lead released?
Both the Lumax DX and The Ilesto DX use the Linox Smart S DX lead. We continue to develop the technology, but have no immediate plans to replace the Linox Smart S DX.
5.) The appropriate A-Sensing rate for the Lumax was advertised at 96.5% – is this number the same for the Ilesto?
The Ilesto DX system was approved based on the same study data as for the Lumax DX System. So yes, that sensing rate is the one that we are able to claim for Ilesto.
6.) Is the remaining 3.5% (non-appropriate atrial sensing) due to lead placement – operator learning curve, or is it a result of a particular disease process – like long term A-Fib, or a previous ablation procedure?
The remaining 3.5% could be attributed to sub-optimal lead placement or incidence of under or over sensing during the protocol-required provocative assessments for sensing. Each patient was evaluated for sensing in 4 different states (lying on back, on side, deep breathing, and hands pressing together) in order to emulate what could be expected in daily activities. It was during these periods that some under and over sensing of atrial signal occurred which is not unexpected.
Stay tuned for part two of this interview later this week!