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Commercial multiple electrode lead technology for cardiac disease

Periodic Reporting for period 4 - AXONE (Commercial multiple electrode lead technology for cardiac disease)

Reporting period: 2020-01-01 to 2020-12-31

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 the European project
- Knowledge regarding hemodynamic benefit of the expected product has been acquired during preclinical experimentation and preliminary communication done in European congress
- Axone design of the system has been validated for easy handling and implantation technics with 2 Acute clinical studies, 50 patients in total.
- Chronic performance has been verified through preclinical testing and Biocompatibility performed after 3 months and 12 months.
- All processes and components have been validated according to the state of the art standards
- Technology has been fully validated for chronic use in human from a mechanical, electrical, Biocompatibility and sterility standpoint
- 2 communication at European Hear Rythm Association (EHRA) congress in 2019 and 2021, HRS in 2020.
- 4 Scientific publications have been Granted
- Axone technical and clinical dossier has been prepared in line with the new MDR regulation system
- Astral chronic clinical study to demonstrate safety and performance in Human has been launched (Phase 1) with 16 patients included
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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