A minimally invasive and durable endograft fastening solution for Abdominal Aortic Aneurysm (AAA)

Informations projet

aortoseal

N° de convention de subvention: 190131747

DOI

10.3030/190131747

Projet clôturé

Date de signature de la CE 16 Decembre 2022

Date de début 1 Février 2023

Date de fin 31 Juillet 2025

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 6 046 607,50

Contribution de l’UE

€ 2 499 999,00

Coordonné par

ENDORON MEDICAL LTD.
Israel

Periodic Reporting for period 2 - aortoseal (A minimally invasive and durable endograft fastening solution for Abdominal Aortic Aneurysm (AAA))

Période du rapport: 2024-02-01 au 2025-07-31

Résumé du contexte et des objectifs généraux du projet

AAA is a focal enlargement of the abdominal aorta below the renal arteries and is found in up to 4 million patients globally each year. If left untreated it can lead to aneurysm rupture and be fatal in a few hours. It is therefore imperative to provide early, prophylactic treatment of AAA before a rupture occurs. However, the two current leading treatments have major weaknesses. Open surgery is a durable, life-long solution, but can only be performed on low-risk patients (22% of patients). The alternative, EVAR (78%), is minimally invasive with lower immediate risks, but is a much shorter-term solution. EVAR patients require constant monitoring through CT scans (which expose the patient to radiation) to check for graft migration and endoleak. When these inevitably occur, the patient must undergo further interventions which raise costs, add risk, and reduce long-term patient survival. A solution is greatly needed that combines the long-term durability of open surgery with the low risk, minimal invasiveness of EVAR.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Endoron has successfully developed its inaugural product, Aortoseal, a catheter based endovascular suturing implant designed to seal and secure a stent graft to the aortic wall, ensuring long-term procedural success for Abdominal Aortic Aneurysm (AAA) treatments. The technology patents are granted in countries such as the USA, Japan, Australia and more with expansion into additional global territories, including the EU. The company has completed its Early Feasibility Study and is establishing research sites across various European countries as well as in the US.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The Endoron Solution, Aortoseal, an endo -sealing Device, is an innovative fixation device based on an intravascular self-stapling (“suture-like”) mechanism to treat AAA EVAR patients. Aortoseal is the only solution for treatment of AAA that combines the long-term durability of a hand sewn suture, with the minimal invasiveness of EVAR. Today, 22% of all cases are recommended to have open surgery to treat their AAA. With Endoron Solution patients can avoid open surgeries which are very risky with higher mortality rates.

Endoron's clean room team

Prof. Kolvenbach testing the Aortoseal

Endoron's solution

Endoron team successfully completing a FIH case

Endoron's inventor Dr. Ron Karmeli

Comapany's logo