New materials for revolutionary, branched, non-supported stents (CUSTOMI™) for aortic-arch endovascular repair

Project Information

CUSTOMI Arch

Grant agreement ID: 735223

DOI

10.3030/735223

Project closed

EC signature date 11 July 2016

Start date 1 August 2016

End date 31 January 2017

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ENDONOV
France

Periodic Reporting for period 1 - CUSTOMI Arch (New materials for revolutionary, branched, non-supported stents (CUSTOMI™) for aortic-arch endovascular repair)

Reporting period: 2016-08-01 to 2017-01-31

Summary of the context and overall objectives of the project

ENDONOV

SME Instrument Phase 1 FINAL REPORT Summary

Aortic dissection and aneurysms are the two most common life-threatening disorders affecting the aorta. Unless they are treated immediately, they result in shock and death in 80% of cases. However, according to Prof. Koskas, today up to 50% of patients with a high surgical risk cannot be treated with traditional open surgery. This implies that new and less invasive interventions are urgently needed. This is not only a European challenge, but a global one that impacts patients worldwide.
Endonov is developing a disruptive solution called the CUSTOMI® Arch Branched stent system to overcome these existing problems.
New woven fabric materials and advanced manufacturing procedures are playing a crucial role in CUSTOMI®’s unique design and fabrication. For the first time, smaller, tailor-made and multi-branched stent-grafts will be able to take the shape of the complex aortic arch anatomy of each patient. This medical device will be implanted and positioned with greater precision using an advanced sensor guided delivery system. This will allow to treat much more patients with different arch anatomies and ensure a longer term durability of the device.

The specific objectives of the feasibility study were to cover technological, IP and economic feasibility for the Customi ® Arch Branched System. In particular, to validate both the new fabric and delivery system. This feasibility study was essential, and a first step before moving forward to preclinical and clinical trials during the SME Instrument Phase 2.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During this first phase, we have been able to validate the capability of our main partner SATAB to develop and manufacture a new generation of textile. It was very important to first ensure it before engaging further in new development. The comparable material that we have produced and tested outperforms in many ways our current supplier’s. The development of a new polyethylene based material and weaving technique will be part of our next phase of development.

In order to position the device in a complex 3D environment, a new advanced delivery system must be developed. Thanks to the work done in the present phase, we now have a full specification as well as preliminary drawings. Our partner Transluminal is now ready to supply the first prototypes.

Thanks to SME instrument phase 1, we have confirmed the interest of our research all well as validated some major hypothesis. In particular regarding marketing, we were able to confirm and validate the existence of the unmet medical need we are addressing, analyzing key stakeholders, refining our market access strategy and compute future revenue. We are now ready to engage in the full development of a device that will enable health professionals to treat much more patients.

A complete status of the company strong IP position is given in this report, however a full analysis of our freedom to operate will be performed at a later stage of the project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

We are on our way to produce a thinner and stronger sheath material that will surpasse any of existing textile available on the market. Without such advanced research and its consequences on the reduction of the overall size of the device, the develpment of a specific endo prothesis to treat the aortic arch aneuvrism will be much more difficult.

In fact, as demonstrated in our report, none of the current players (and we are talking of very large US corporations) have shown any convincing progres over the last years.

The market available to the company that will be able to finalise the development of such a device represents more that €120 M for that one device only.

Moreover, the availability of the new device will allow patients that have no or unsatisfactory solutions to be much better treated.

Picture 2- Tensile strength testing set up

Picture 9 - Aortic Arch open studies

Picture 8 - Non aortic arch competition offering

Picture 10 - Competion feature positionning