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Commercial multiple electrode lead technology for cardiac disease

Periodic Reporting for period 3 - AXONE (Commercial multiple electrode lead technology for cardiac disease)

Reporting period: 2019-01-01 to 2019-12-31

CRT is one of the possible treatments and is indicated in Heart Failure patients with a desynchronization of the 2 ventricles. This desynchronization affects about 10% of total Heart Failure population . It is estimated that 400 patients per million/population per year might be suitable for CRT.

Indeed, one of the critical components for the success of the CRT therapy is the placement of the LV lead. In contrary to the other leads, the LV lead is positioned by passing through very narrow, tortuous veins: the coronary venous system of the left ventricle, which can be very different from one patient to another.

This project will finalise the development and begin the commercialisation of a pacemaker cardiac lead that is 5 times smaller in diameter than state-of-the-art leads today. A lead is a thin insulated wire structure connected to the pacemaker and designed to electrically stimulate and sense the heart. This lead is designed to pace the left ventricle (LV) of the heart through left ventricular coronary venous access.

The miniaturization of the AXONE lead has two major advantages:
1. Because of its small size, AXONE can enter small veins that are not accessible to current leads on the market. As a result, it can be positioned “anywhere” in the coronary venous system, allowing cardiologists to implant the lead in the targeted left ventricular vein.
2. Because of its multipolarity (IS4), AXONE allows pacing of distant zones on the left ventricle. Therefore, this single lead can deliver “true” multisite pacing and subsequently potential better resynchronization due to the enlarged pacing area.
At the end of this third year:
- Knowledge regarding hemodynamic benefit of the expected product has been acquired during preclinical experimentation and preliminary communication done in European congress
- A first acute clinical study was completed using a first generation lead design showing good navigability and promising performances
- Final design of the system has been specified and prevalidated according to clinical feed back and Advisory Board meetings
- Technology gains maturity in fulfiling requirements for both robustness and fatigue resistance
- First communication at European Hear Rythm Association (EHRA) congress in March 2019
"We expect for the end of the project to have the safety of this new ""microcatheter based"" cardiac resynchronization therapy solution validated.
Expected results before the end of the project:
- Publications around this new implantation technics
- Base technology validated for further developments through clinical studies, and new clinical approaches
"
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