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

Project Information

aortoseal

Grant agreement ID: 190131747

DOI

10.3030/190131747

Project closed

EC signature date 16 December 2022

Start date 1 February 2023

End date 31 July 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 6 046 607,50

EU contribution

€ 2 499 999,00

Coordinated by

ENDORON MEDICAL LTD.
Israel

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

Reporting period: 2024-02-01 to 2025-07-31

Summary of the context and overall objectives of the project

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.

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

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.

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)

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