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

Informazioni relative al progetto

aortoseal

ID dell’accordo di sovvenzione: 190131747

DOI

10.3030/190131747

Progetto chiuso

Data della firma CE 16 Dicembre 2022

Data di avvio 1 Febbraio 2023

Data di completamento 31 Luglio 2025

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 6 046 607,50

Contributo UE

€ 2 499 999,00

Coordinato da

ENDORON MEDICAL LTD.
Israel

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

Periodo di rendicontazione: 2024-02-01 al 2025-07-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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

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