News from AMT Medical
On track to hit the next milestones with the Elana® Heart Bypass System
The market introduction of AMT Medical’s Elana Heart Bypass System is well on track. We successfully operated on the first ten patients in Phase I of the SAFE-CAB trial, establishing the safety and feasibility of our Elana Heart Bypass System. The larger Phase II, with 75 enrolled patients, has now started. In addition, final discussions with the U.S. Food & Drug Administration (FDA) have now started to commence the Early Feasibility Trial in the U.S.
The Elana Heart Bypass System enables less invasive and more standardized Coronary Artery Bypass Grafting (CABG) surgery – for both patients and surgeons. Instead of using needle and thread, surgeons use this innovative clip and laser technology to connect a new bypass graft vessel to the blocked vessel in a more systematic and predictable way. Elana doesn’t necessarily require the use of a traditional heart-lung machine. In fact, it can be used in a less or minimally invasive setting, by completely bypassing the need for open heart surgery.
Delivering Phase II in Europe
Operating the first patients in the US
Investors are taking an interest
A growing organization
Jorrit Kelderman Chief Financial Officer
Rachel Derksen Director Clinical Affairs
Femke Valkenburg Quality & Regulatory Manager
Yuri van Buren Cleanroom employee
Our own Academy
Part of the market introduction is training surgeons on how to perform the Elana Heart Bypass Procedure. We do this with internal training and our own Elana Academy which we aim to expand towards continuous education in September.
Our Elana Academy is a training and education center aimed at helping a new generation of surgeons explore and ultimately adopt a next-generation technology. Our Elana Academy includes:
- Practical tutorials and training for healthcare professionals. This includes two CME-accredited courses that dive into the theory of CABG surgery and the emergence of next-generation Elana Heart Bypass Technology – all delivered by world-renowned experts.
- The ability to schedule bespoke one-to-one Elana training sessions with our experts – who gladly answer all questions.
- The usage of the extensive video library providing in-depth explanations and tutorials on the technology from influential cardiothoracic surgeons and renowned scientists.
- Hands-on training through our Elana Skills Lab sessions, which give surgeons practical experience of the technology in real-life models.
Staying up to date with the latest medical technologies and treatments is important to us. That’s why our Clinical Team recently hosted an internal training session on heart and cardiovascular diseases. Over the course of two days, we took a deep dive into the intricacies of Coronary Artery Disease (CAD) and CABG. We explored the latest research and techniques and discussed the best ways to implement these practices in our own work. Including, of course, the Elana Heart Bypass System.