Periodic Reporting for period 2 - DefiPace-System (Market introduction of a revolutionary innovative cardiac stimulation system for the prevention and termination of post-operative atrial fibrillation)
Période du rapport: 2021-06-01 au 2023-11-30
Description of the action context:
The incidence of cardiac surgeries is increasing world-wide in view of the demographic change. Cardiac surgery carries a significant amount of risk as on average 60% of patients develop postoperative atrial fibrillation, by far the most frequently occurring complication after cardiac surgery. Clinical investigations show a significant increase in morbidity, mortality and duration of treatment and hospital stay.
Therefore a new system is being developed, that allows physicians to prevent and terminate postoperative atrial fibrillation (POAF) in all patients. It is the only system which combines standard stimulation, bi-atrial pacing as well as epicardial low-energy cardioversion in one hand-held easy-to-use device. Target customers are all patients undergoing cardiac surgery world-wide. Patients will benefit from the availability of such system, as it intends to reduce the negative impact of post-operative atrial fibrillation, reducing morbidity, mortality and reducing treatment time and hospital stay. This is expected to have beneficial outcome for society in regards to hospital and insurance costs, and hospital bed availability, which has been a factor of crucial importance, as the Covid-19 pandemic has taught us.
The incidence of cardiac surgeries is increasing world-wide in view of the demographic change. Cardiac surgery carries a significant amount of risk as on average 60% of patients develop postoperative atrial fibrillation, by far the most frequently occurring complication after cardiac surgery. Clinical investigations show a significant increase in morbidity, mortality and duration of treatment and hospital stay.
Therefore a new system is being developed, that allows physicians to prevent and terminate postoperative atrial fibrillation (POAF) in all patients. It is the only system which combines standard stimulation, bi-atrial pacing as well as epicardial low-energy cardioversion in one hand-held easy-to-use device. Target customers are all patients undergoing cardiac surgery world-wide. Patients will benefit from the availability of such system, as it intends to reduce the negative impact of post-operative atrial fibrillation, reducing morbidity, mortality and reducing treatment time and hospital stay. This is expected to have beneficial outcome for society in regards to hospital and insurance costs, and hospital bed availability, which has been a factor of crucial importance, as the Covid-19 pandemic has taught us.
The objectives of the work performed
Several objectives have been pursued and carried out in the first year of the funding period, which includes the clinical application testing of the hand-held device and related software improvement steps. On the electrode /cardiac implantation side it includes clinical application of the system, as well as development of additional variants based on customer feedback. The development required submission for CE mark. Furthermore, a single-center clinical study was carried out, and preparation for a larger clinical study was initiated.
Main results achieved:
Successful clinical testing of the device and electrodes, CE marking of the complete system, completion of a clinical study, which is in submission for publication, and finalization of the study synopsis and recruitment of 10 centers for a large international multi-site clinical trial.
Several objectives have been pursued and carried out in the first year of the funding period, which includes the clinical application testing of the hand-held device and related software improvement steps. On the electrode /cardiac implantation side it includes clinical application of the system, as well as development of additional variants based on customer feedback. The development required submission for CE mark. Furthermore, a single-center clinical study was carried out, and preparation for a larger clinical study was initiated.
Main results achieved:
Successful clinical testing of the device and electrodes, CE marking of the complete system, completion of a clinical study, which is in submission for publication, and finalization of the study synopsis and recruitment of 10 centers for a large international multi-site clinical trial.
The easy-to-use system elegantly combines different post-operative therapies in one system, allowing intuitive handling for clinical staff similar to currently, separately used devices. The treatment modalities have been proven to be effective and beneficial for the patients, resulting in quick termination of atrial fibrillation. This is expected to lead to a cost reduction for cardiac surgery centers in the amount of at least €1,000per day/patient and it has the potential to significantly improve patient health and reduction in post-operative hospital stay, and an overall reduction of morbidity and mortality related to post-operative atrial fibrillation.
2. Implications - socio-economic implications:
Beyonc the cliniacl implication the product is expected to have, the work on the project has already supported and created jobs in product management, medical writing, technical documentation, regulatory affairs, clinical research office, product management and clinical assistant jobs.
2. Implications - socio-economic implications:
Beyonc the cliniacl implication the product is expected to have, the work on the project has already supported and created jobs in product management, medical writing, technical documentation, regulatory affairs, clinical research office, product management and clinical assistant jobs.