AMT Medical's Sutureless ELANA Bypass System Meets Primary Endpoint in First Prospective CABG Trial
核心洞察
The SAFE-CAB II trial demonstrated that the ELANA® Anastomotic System (搜索) achieved a device-related serious cardiac event rate of 2.9% at one year, statistically non-inferior to the historical surgical benchmark (p = 0.0033).
Six-month bypass graft patency reached 92.5% across the full cohort and 97.5% in the subgroup treated with the latest-generation laser catheter, matching the upper range of hand-sewn bypass outcomes.
The ELANA system replaces hand-sewn anastomosis with a sutureless, laser-assisted six-step procedure that maintains continuous coronary blood flow, potentially enabling broader adoption of minimally invasive and robotic CABG.
The one-year results of the SAFE-CAB II clinical trial, published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS), provide the first prospective clinical evidence that a sutureless, laser-assisted anastomotic system can safely and effectively create the most critical connection in coronary artery bypass grafting (CABG) — all without interrupting blood flow to the beating heart.
The ELANA® Anastomotic System (搜索), developed by Dutch medical technology company AMT Medical B.V. (搜索), replaces the hand-sewn bypass graft connection with a small titanium clip and a precisely controlled laser pulse. The SAFE-CAB II trial, conducted at St Antonius Hospital in Nieuwegein, The Netherlands, in collaboration with Deutsches Herzzentrum der Charité in Berlin, enrolled 71 patients undergoing elective CABG between June 2023 and September 2024. Patients had an average age of 71 years and received an average of 3.5 bypass connections per procedure.
Primary Endpoint and Safety Results
The trial met its primary endpoint: device-related serious cardiac events at one year occurred in 2.9% of patients, which was statistically non-inferior to the historical surgical benchmark (p = 0.0033). The total one-year serious cardiac event rate was 8.7%, consistent with expectations. No safety concerns related to the device were identified by the independent Data Safety Monitoring Board.
" For the first time, a rigorous prospective trial shows that the most challenging step of a bypass operation can be performed without sutures on a beating heart, and without ever interrupting blood flow to the patient's coronary artery," said Bart P. van Putte, MD PhD, Principal Investigator at St Antonius Hospital and Amsterdam UMC. "That is genuinely new. It is the technical breakthrough the field has been waiting for to make modern, less invasive bypass surgery available to many more patients than today."
Patency Data
Six-month angiographic patency — the rate at which bypass connections remained fully open — was 92.5% across the full trial cohort. In the subgroup treated with the latest-generation laser catheter, patency rose to 97.5%, matching the upper range of outcomes reported for the best hand-sewn bypasses. All angiographic data were independently reviewed by Cardialysis, a leading academic core laboratory in cardiovascular research based in Rotterdam.
In a subset of patients with angiographically uncertain results, intravascular ultrasound confirmed that the bypass connection was fully open and unobstructed.
How the ELANA System Works
Originally developed at UMC Utrecht for neurovascular bypass surgery — where it received CE marking in 2008 and FDA clearance in 2012, with over 1,000 patients treated worldwide — the ELANA platform has been re-engineered over the past decade specifically for coronary anatomy. The system employs a defined six-step mechanical sequence: the surgeon attaches a small titanium clip to the coronary artery and then fires a controlled laser pulse that creates a clean opening within the clip. Critically, the connection is made before the artery is opened, meaning blood continues to flow to the heart muscle throughout the procedure. The technique is described in detail in a companion technical publication in the Journal of Visualized Surgery.
This approach replaces the hand-sewn step requiring 8–12 stitches per anastomosis — a technique that has remained essentially unchanged since the 1960s and is widely cited by surgeons as the primary obstacle to broader adoption of minimally invasive and robotic bypass techniques.
Clinical and Economic Implications
Coronary artery disease (搜索) remains the leading cause of death globally, with approximately one million CABG procedures performed annually. A sutureless, flow-preserving connection is viewed as a foundational enabler of minimally invasive and robotic CABG, which published literature associates with smaller incisions, less surgical trauma, shorter hospital stays, and faster return to daily life.
An internal health-economic assessment by AMT Medical, based on benchmark data from major CABG literature, estimates that direct CABG-related hospital costs could be reduced by 35–50% relative to conventional open-chest CABG at scale, with additional productivity gains for working-age patients through faster return to work.
Regulatory and Commercial Next Steps
With SAFE-CAB II now peer-reviewed and published, AMT Medical is advancing on multiple regulatory fronts. The company is preparing CE marking submissions for open and MIDCAB (minimally invasive direct coronary artery bypass) indications under the EU Medical Devices Regulation. In parallel, it is preparing an Investigational Device Exemption (IDE) submission to the U.S. Food and Drug Administration for an Early Feasibility Study, with discussions underway with several leading U.S. academic cardiac surgery centers.
The company also plans to initiate next-generation clinical trials in minimally invasive and robotic settings, including a planned multivessel investigation, while continuing the two-year follow-up of the SAFE-CAB II cohort.
AMT Medical has raised over EUR 40 million to date, including a USD 25 million Series B in 2025 led by Bender Analytical Holding B.V. (搜索), with participation from Invest-NL, the European Innovation Council Fund, and Oost NL. Earlier this year, the company appointed Geert van Gansewinkel as CEO; he previously led GATT Technologies through CE marking, FDA PMA approval, and acquisition by Johnson & Johnson in 2025.
"Peer-reviewed publication in JTCVS is a defining milestone for AMT Medical. It places the ELANA platform on a solid clinical foundation, independently adjudicated and reviewed by the international cardiothoracic surgery community," said van Gansewinkel. "Our goal is simple: to make high-quality bypass surgery, with faster recovery and fewer complications, available to far more patients than today."
The ELANA® Anastomotic System (搜索) for coronary artery bypass remains an investigational device and has not yet received CE marking or FDA clearance for commercial sale.