Periodic Reporting for period 6 - SAFE-CAB (Laser-Assisted Surgical System to Revolutionize Cardiac Bypass Surgeries)
Reporting period: 2022-03-01 to 2023-06-30
Objectives
The vision of the SAFE-CAB consortium is to make the minimally invasive (closed chest) coronary bypass surgeries available to all cardiothoracic surgeons as a novel standard of care. This will bring a substantial improvement in surgery outcomes (shorter recovery times, less complications and improved survival) and drastically reduced health care costs. The goal of the SAFE-CAB project is to bring to market a first-of-its-kind minimally invasive surgical system for cardiac bypass surgery. The breakthrough SAFE-CAB technology will replace high-risk open-heart surgeries (performed on arrested heart with interrupted blood flow using complex hand suturing) with safer, faster, suture less procedure on beating heart without the need for opening the chest or arresting the blood flow.
Conclusions of the project:
The SAFE-CAB project lead to the first steps to the market entry of the ELANA Heart Bypass System through performing extensive bench testing, the development of an adequate surgical training program, and conducting a first-in-man clinical validation trial to evaluate safety and feasibility.
The short-term results of the 10 patients of the first-in-man trial showed that the ELANA Heart Bypass System is safe and feasible. Based on these promising results, ethical approval was achieved to start a second phase of this trial including 75 additional patients with a longer follow-up period. The objective of the second phase of the trial is to further evaluate the safety and effectiveness of the system. The second phase is still ongoing and will be completed outside the timelines of the SAFE-CAB project.
Moreover, the SAFE-CAB project enabled dessimination of the sutureless bypass technique among surgeons by actively participating different events (such as ESCVS). All projects together are a great contribution to the conversion to less and minimally invasive bypass surgery with improved clinical outcomes.
The vision of the SAFE-CAB consortium is to make the minimally invasive (closed chest) coronary bypass surgeries available to all cardiothoracic surgeons as a novel standard of care. This will bring a substantial improvement in surgery outcomes (shorter recovery times, less complications and improved survival) and drastically reduced health care costs. The goal of the SAFE-CAB project is to bring to market a first-of-its-kind minimally invasive surgical system for cardiac bypass surgery. The breakthrough SAFE-CAB technology will replace high-risk open-heart surgeries (performed on arrested heart with interrupted blood flow using complex hand suturing) with safer, faster, suture less procedure on beating heart without the need for opening the chest or arresting the blood flow.
Conclusions of the project:
The SAFE-CAB project lead to the first steps to the market entry of the ELANA Heart Bypass System through performing extensive bench testing, the development of an adequate surgical training program, and conducting a first-in-man clinical validation trial to evaluate safety and feasibility.
The short-term results of the 10 patients of the first-in-man trial showed that the ELANA Heart Bypass System is safe and feasible. Based on these promising results, ethical approval was achieved to start a second phase of this trial including 75 additional patients with a longer follow-up period. The objective of the second phase of the trial is to further evaluate the safety and effectiveness of the system. The second phase is still ongoing and will be completed outside the timelines of the SAFE-CAB project.
Moreover, the SAFE-CAB project enabled dessimination of the sutureless bypass technique among surgeons by actively participating different events (such as ESCVS). All projects together are a great contribution to the conversion to less and minimally invasive bypass surgery with improved clinical outcomes.
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.
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.
The ELANA technique is an anastomotic technique to be used in coronary bypass surgery. The ELANA Heart Bypass System is specifically designed for the anastomosis between the donor graft and the coronary artery in a beating heart CABG-procedures. The SAFE-CAB project is to bring the ELANA Heart Bypass System to practise in cardiothoracic sugery so it can be available to the large population of patients that needs to receive Coronary Artery Bypass Grafting (CABG) every year.
The major innovations resulting from this project are; 1) the receiving vessel does not have to be temporarily occluded during the procedure, 2) the anastomotic size and form are standardized by using the excimer laser, and 3) the technique might boost the run for less invasive CABG procedures. This pushes coronary bypass surgery beyond the current state-of-the-art of hand-sewn anastomoses and its associated well-reported anastomotic complications; 1) insufficient arteriotomy (size, orientation, damage), 2) constriction of the anastomotic site (with the running suture functioning as a purse-string), 3) anastomotic leakage, and 4) inadvent suturing of the posterior coronary artery wall.
With this innovation minimally invasive coronary bypass surgery will be one step closer. The SAFE-CAB project contributes to improving CABG procedures so they will be safer, which will eventually lead to faster hospital discharge, less complication of surgery and greater accessibility of the procedure to all patient. Next to that it can alleviate some pressure from the public healthcare system due to the potential to shorten hospital stays and prevention of redo procedures.
The major innovations resulting from this project are; 1) the receiving vessel does not have to be temporarily occluded during the procedure, 2) the anastomotic size and form are standardized by using the excimer laser, and 3) the technique might boost the run for less invasive CABG procedures. This pushes coronary bypass surgery beyond the current state-of-the-art of hand-sewn anastomoses and its associated well-reported anastomotic complications; 1) insufficient arteriotomy (size, orientation, damage), 2) constriction of the anastomotic site (with the running suture functioning as a purse-string), 3) anastomotic leakage, and 4) inadvent suturing of the posterior coronary artery wall.
With this innovation minimally invasive coronary bypass surgery will be one step closer. The SAFE-CAB project contributes to improving CABG procedures so they will be safer, which will eventually lead to faster hospital discharge, less complication of surgery and greater accessibility of the procedure to all patient. Next to that it can alleviate some pressure from the public healthcare system due to the potential to shorten hospital stays and prevention of redo procedures.