HASI Project: ILR

Imperial Implantable Electro-Mechanical Coupling Loop Recorder: In-vivo human testing (ILR)

The 40% of shocks delivered by Implantable Cardioverter Defibrillators (ICDs) are unnecessary because ICDs rely solely on ECG signals for their decisions. They cannot distinguish between artefact, arrhythmias not requiring a shock (because haemodynamics are maintained) and arrhythmias requiring a shock. Resulting in unnecessary shocks distress the patient and damage the heart.

Previous attempts to use haemodynamics to limit shocks have not been reliable enough for clinical adoption. We have developed and patented a unique combinatorial algorithm for electrograms alongside haemodynamic signals, that is vastly more reliable than all previous methods.

We have proven our solution in humans using externally placed sensors. The crucial step now is a demonstration that it works equally well with internally placed sensors. We have therefore created an implantable device that monitors haemodynamics and cardiac electrograms, for internal testing in humans.

Market 1: 250,000 defibrillators are implanted annually, each costing ~£10,000. Adding our technology would slash unnecessary shocks at least 10-fold making licensee devices immensely more desirable and safer. Market 2: 25% of people experience syncope (fainting). Investigations can include implantable ECG loop recorders (ILR). In most patients, however, the haemodynamic collapse occurs before (or even without) arrhythmia, and therefore treatment with a cardiac device won’t help. Current ILRs cannot distinguish these, causing mistaken diagnoses. Our Imperial ILR will distinguish these, giving it unique diagnostic power.

The expected outcome from HASI: Data from within humans will trigger partnership from Vendors or funding from Venture Capital. Currently TRL-3. This award will bring us to TRL- 6.