WP1: Bench testing and biological risk assessment/safety
Bench testing has been performed on (parts of) the ELANA Heart Clip and the ELANA Heart Laser Catheter including mechanical testing, fatigue testing, burst pressure testing, physical testing and shelf life determination. Based on the results, the ELANA Heart Clip and ELANA Heart Laser Catheter have officially been released for clinical investigation.
A serial manufacturing processes of the ELANA Heart Clip and ELANA Heart Laser Catheter was developed and documented in a procedure, work instructions and forms to document the process and its traceability.
A first batch of 23 ELANA Heart Clips and 15 ELANA Heart Laser Catheters has been produced for clinical use in the FIH trial.
WP2: Clinical validation studies and medical affairs
WP2 the initial phase of a feasibility and safety trial for the SAFE-CAB system. The first phase of the trial known as the First-in-Human (FIH) trial, took place at St. Antonius Ziekenhuis in the Netherlands. The primary objective of the FIH trial was to assess the success rate and safety of the SAFE-CAB device in 10 adult patients who were scheduled to undergo CABG surgery. An interim analysis was conducted after the final patient completed 30 days post-operation, spanning from April to July 2022. The evaluation at this point focused on Major Cardiac Events (MACEs), including mortality, the need for revascularization, and myocardial infarction. Notably, no MACEs were observed during this period. After finalization of the FIH trial, the protocol and other study documentation were updated in preparation for the second phase of the trial. The second phase of the trial will be completed outside the timelines of the SAFE-CAB project.
WP3: Regulatory Affairs/ Quality Assurance
In order to commercialize the Elana Heart Bypass System, AMT aims to gain market access both in the EU and the US.
For the EU, a strategy to claim conformity with the General Safety and Performance Requirements of the Medical Device Regulation (MDR) 2017/745 is utilized. As part of this strategy, AMT received its certification to ISO 13485:2016 in May 2023 and now manufactures the devices part of the Elana Heart Bypass System under this quality management system for the planned clinical trials. With this combined clinical evidence, and other technical documentation required to claim conformity to the MDR, AMT aims to apply for MDR submission for receiving CE certification in 2024-2025.
At the same time, AMT is planning a clinical feasibility study in the US, in order to apply for an investigational device exemption (IDE) application for a clinical investigation in a larger number of patients. This IDE data is required to subsequently apply for a premarket approval application (PMA) after which the devices can be placed on the US market commercially.
WP4: Dissemination, exploitation and training
The Cardiac Biosimulator was adapted to be used as a training and R&D tool for the ELANA Heart Bypass Solution. The simulator was developed from a large, hard to transport system to a small and highly portable systemand deployed at several conferences to demonstrate the ELANA Heart Bypass Solution in particular or the use of the simulator as a training tool in general.
In addition to the Cardiac Biosimulator, a dummy patient was developed to train cardiothoracic surgeons for CABG in an open setting in a more realistic environment, contributing positively to the learning curve and to the number of in-vivo training cases that is required in order to start with clinical cases. Moreover, the dummy patient was also used to give a live demonstration on the ESCVS congress 2023 to show cardio- and vascular surgeons the procedure of the Elana Heart Bypass System.
