Periodic Reporting for period 1 - ELANA® (Bypassing open heart surgery with Excimer Laser Assisted Non Occlusive Anastomosis (ELANA®))
Período documentado: 2022-10-01 hasta 2023-09-30
A considerable number of people every year with coronary heart disease undertake invasive heart bypass surgery. However, this procedure has a high risk of complications and requires long recovery times. Co-funded by the European Innovation Council, the ELANA® project proposes to develop an alternative, minimally invasive operation that uses small incisions in the chest to perform the bypass. The procedure employs an innovative clip that overcomes the need for blood vessel suturing. Moreover, it eliminates the need for a heart-lung machine, reducing associated risks and shortening the recovery time. The project will undertake clinical validation of this novel approach and activities for market authorisation.
We will revolutionise the medical field by replacing expensive, invasive and high-risk open-heart surgery, with “keyhole” minimally invasive surgery (MIS) to treat coronary artery disease (CAD). Our ELANA® technology enables reproducible coronary artery bypass grafting (CABG) surgery
without the need of heart arrest and suturing, thus avoiding the need to open the patient’s chest. This is realised with an innovative clip which circumvents the need of suturing of blood vessels altogether. By realising closed-chest CABG, ELANA® reduces not only the risks associated with
traditional CABG, such as bleeding, stroke and wound infection, but also significantly shortens recovery times. As a result, ELANA® will reduce direct healthcare costs of CABG procedures by over 50%.
We will revolutionise the medical field by replacing expensive, invasive and high-risk open-heart surgery, with “keyhole” minimally invasive surgery (MIS) to treat coronary artery disease (CAD). Our ELANA® technology enables reproducible coronary artery bypass grafting (CABG) surgery
without the need of heart arrest and suturing, thus avoiding the need to open the patient’s chest. This is realised with an innovative clip which circumvents the need of suturing of blood vessels altogether. By realising closed-chest CABG, ELANA® reduces not only the risks associated with
traditional CABG, such as bleeding, stroke and wound infection, but also significantly shortens recovery times. As a result, ELANA® will reduce direct healthcare costs of CABG procedures by over 50%.
Main Achievements
• The ELANA Heart Clip is optimized by changing de grapping point on the top instead of the back, so less space for application is needed. The laser catheter is adapted to a more standardized plug and play principle. The catheter is also more flexible and the tip is made more rigid so fixation of the laser catheter in the clip is more easy and standardized.
• The applicators and fixation device are optimized. De applicators are straight like a foreceps and thus for the end user easy and comfortable in use. The Fixation device is changed according the changed laser catheter. There is only one way the fixation device fits on the laser catheter.
• The ELANA kits for the first 25 patients are fabricated.
• Ethical approval is obtained (see attachment) on the final protocol
• Surgeons are trained in Amsterdam to start the clinical trial
• The ELANA Heart Clip is optimized by changing de grapping point on the top instead of the back, so less space for application is needed. The laser catheter is adapted to a more standardized plug and play principle. The catheter is also more flexible and the tip is made more rigid so fixation of the laser catheter in the clip is more easy and standardized.
• The applicators and fixation device are optimized. De applicators are straight like a foreceps and thus for the end user easy and comfortable in use. The Fixation device is changed according the changed laser catheter. There is only one way the fixation device fits on the laser catheter.
• The ELANA kits for the first 25 patients are fabricated.
• Ethical approval is obtained (see attachment) on the final protocol
• Surgeons are trained in Amsterdam to start the clinical trial