A novel system for closing the left atrial appendage (LAAO)
A comprehensive R&D project to create a specialized clamp and applicator for closing the left atrial appendage
Project Details
The project involves the design of a medical device and its production technology
Project Goal
The goal of the AtriClamp project is to implement a research and development project consisting of creating a clip and applicator for closing the left atrial appendage of the heart. The developed device serves as an additional means of preventing the causes of stroke, which translates into improving the quality of life of patients. The project also includes the development of manufacturing technology with a view to its further validation and potential market implementation.
About the Product
AtriClamp is an innovative system designed to close the left atrial appendage (LAAO), aimed at minimizing the risk of stroke in patients with atrial fibrillation. The product is a system consisting of a clip and a dedicated applicator. The clip is applied to the left atrial appendage, which is mechanically and electrically isolated from the atrium as a result of the procedure. Effective closure of the left atrial appendage reduces the risk of formation and movement of clots that could lead to stroke.
Target Groups
The AtriClamp project targets patients with non-valvular atrial fibrillation - particularly those with long-term persistent forms of the disease - who face an elevated stroke risk and are suitable candidates for surgical ablation procedures. The developed medical device is intended for use by experienced cardiac surgeons performing left atrial appendage closure (LAAO) procedures, serving as a dedicated tool designed for safe and effective use in operating room conditions.
Expected Results
Expected Results
The AtriClamp project will result in the development of a medical device and associated design solutions. Following completion of the R&D phase and subsequent validation, the project outcomes are expected to:
- improve the safety and effectiveness of left atrial appendage closure procedures
- reduce procedural costs through the use of technologies suitable for scalable manufacturing
- eliminate the need to pass the clip through the appendage, potentially reducing the risk of thrombus displacement
- enable the procedure to be performed epicardially, without entering the heart
- allow the clip to be repositioned and retrieved using the same applicator, potentially reducing the need for additional surgical interventions.
Project Scope
Project Scope
The scope of the project includes research and development activities aimed at commercializing the product. The planned activities include:
- design and prototyping of the medical device, including material selection, structural design, sample production, and mechanical and functional testing to develop and optimize the prototype
- application of advanced engineering methods, such as finite element method (FEM) simulations, strength testing, and the development of research protocols
- an iterative development process involving multiple rounds of testing and refinement of components and subassemblies based on test results
- preclinical and clinical studies to verify the functionality, safety, and effectiveness of the product under real-world conditions.
Patented design and functionalities
Patented design and functionalities
AtriClamp is protected by patent on key markets, including in Poland, China, Japan, Canada and the U.S. After local patent validation, patent protection can be obtained in other jurisdictions.
The key innovation of retraction and removal of the clip even after its first application has been recognized and protected on one of the most important global markets.
Project funding details
Information about the project funding
The project “AtriClamp – innovative system for closing the left atrial appendage of the heart (LAAO)” is implemented with the support of European Funds, within the Operational Program European Regional Development Fund for Mazovia 2021 - 2027.
The funding allows the implementation of R&D activities involving the design, prototyping, testing and development of the manufacturing technology of the AtriClamp system.
- Total project value: PLN 17,414,110.25
- EU contribution: PLN 8,707,055.12
- Implementation period: 07.03.2024 – 24.12.2027
Project Progress
Below is information on the progress of the R&D activities carried out so far as part of the project
2025
Mechanical Testing of the Clip
Request for proposal directed to research laboratories, including mechanical testing of the AtriClamp clip (30 pcs.) and preparation of a research report.
Pilot Study
Request for proposal regarding the continuation of the procedure for selecting a research unit to conduct a pilot study of the left atrial appendage (LAA) closure system.
AtriClamp Clip Prototyping
Request for proposal regarding the analysis of the AtriClamp clip design in terms of injection molding technology, including preparation of a prototype mold and production of a series of prototype clips with packaging and delivery.
Signing of Project Funding Agreement
Signing of the funding agreement for the project "AtriClamp - an innovative system for closing the left atrial appendage (LAAO)" under the European Funds for Mazovia 2021-2027 program.
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