Periodic Reporting for period 2 - ELANA® (Bypassing open heart surgery with Excimer Laser Assisted Non Occlusive Anastomosis (ELANA®))
Reporting period: 2023-10-01 to 2025-09-30
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.
Several studies, address that the current techniques available to perform OPCAB-surgery in a minimally invasive surgical approach, require dedicated teams in high-volume centers . Therefore, these minimally invasive techniques are still not available for the majority of CABG-patients.
To increase the feasibility of OPCAB surgery with a no-aortic touch handling in a minimal invasive setting, a laser-assisted anastomotic device was developed, the Elana Anastomotic System®. This method ensures a non-occlusive mechanical coronary anastomosis, securing the donor to the target vessel in a side-to-side anastomosis by the forced strength of a clip. The standardized arteriotomy minimizes the possibility of technical error, thus minimizing the chance of early graft failure. The first generations bypasses made with the Elana Anastomotic System are already evaluated successfully in both in vitro, in vivo animal studies , and a first-in-human study (unpublished data).
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%.
Several studies, address that the current techniques available to perform OPCAB-surgery in a minimally invasive surgical approach, require dedicated teams in high-volume centers . Therefore, these minimally invasive techniques are still not available for the majority of CABG-patients.
To increase the feasibility of OPCAB surgery with a no-aortic touch handling in a minimal invasive setting, a laser-assisted anastomotic device was developed, the Elana Anastomotic System®. This method ensures a non-occlusive mechanical coronary anastomosis, securing the donor to the target vessel in a side-to-side anastomosis by the forced strength of a clip. The standardized arteriotomy minimizes the possibility of technical error, thus minimizing the chance of early graft failure. The first generations bypasses made with the Elana Anastomotic System are already evaluated successfully in both in vitro, in vivo animal studies , and a first-in-human study (unpublished data).
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 easier and more 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 easier and more 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
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.