AMT Medical’s sutureless bypass system posts 1-year safety data

AMT Medical says a peer-reviewed clinical trial in The Journal of Thoracic and Cardiovascular Surgery found its ELANA coronary bypass system was safe at one year and kept most bypass connections open at six months. The results could help push minimally invasive and robotic bypass surgery toward broader use.

Why it matters: - Coronary artery bypass grafting is still the most durable treatment for advanced coronary artery disease. - The hardest part of the operation has remained hand-sewing the graft to the coronary artery, a step that limits wider use of minimally invasive and robotic bypass surgery. - SAFE-CAB II is the first prospective clinical evidence that a sutureless, flow-preserving bypass connection can work safely in humans. - The trial suggests a path to more standardized procedures, potentially with shorter recovery times and lower hospital resource use.

What happened: - AMT Medical reported one-year results from the SAFE-CAB II prospective clinical trial in The Journal of Thoracic and Cardiovascular Surgery. - The study tested the ELANA Anastomotic System, which replaces hand-sewing with a laser-assisted, sutureless coronary bypass connection. - The trial ran at St Antonius Hospital in Nieuwegein, the Netherlands, with collaboration from Deutsches Herzzentrum der Charité in Berlin. - Between June 2023 and September 2024, 71 elective CABG patients received the ELANA connection between the left internal thoracic artery and the left anterior descending coronary artery. - Patients had an average age of 71, and the average number of bypass connections per patient was 3.5. - The Journal of Thoracic and Cardiovascular Surgery publication is the flagship journal of the American Association for Thoracic Surgery.

The details: - The primary endpoint was met, with device-related major adverse cardiac events at one year occurring in 2.9% of patients. - That result met the pre-specified non-inferiority threshold, with p = 0.0033. - Six-month patency was 92.5% across the full study. - Six-month patency rose to 97.5% in the subgroup treated with the latest-generation laser catheter. - In patients with uncertain angiographic findings, intravascular ultrasound confirmed the bypass connection was fully open and unobstructed. - Total one-year serious cardiac events were 8.7%. - The independent Data Safety Monitoring Board identified no safety concerns related to the device. - Cardialysis in Rotterdam independently reviewed all angiographic data. - HEMEX AG monitored the trial end to end under independent oversight. - The study was conducted in compliance with the Declaration of Helsinki, the EU Medical Devices Regulation, ISO 14155 and ISO 14971. - The ELANA procedure uses a small titanium clip and a controlled laser pulse to create the bypass opening before the artery is opened, so blood flow continues during the procedure. - The operation follows a defined six-step sequence rather than hand-sewn stitches. - A companion technical paper in Journal of Visualized Surgery describes the six-step procedure in detail. - The original ELANA platform was developed at UMC Utrecht for brain bypass surgery, received CE marking in 2008 and FDA clearance in 2012 for that indication, and has been used in more than 1,000 patients worldwide. - AMT Medical has re-engineered the platform for coronary anatomy and validated it in preclinical work, including ex-vivo human hearts and large-animal studies.

Between the lines: - The company is trying to turn a technically difficult surgical step into a repeatable mechanical process. - That could reduce operator-dependent variation, which matters for hospitals trying to scale minimally invasive CABG. - The study data support the pitch that the ELANA system is not just a concept, but a clinically tested enabling technology. - The economic case is also part of the strategy: AMT Medical cites internal modeling that estimates direct CABG hospital costs could fall 35% to 50% at scale versus conventional open-chest CABG. - Those savings would come from shorter recovery, fewer complications and shorter ICU and hospital stays associated with minimally invasive approaches. - CEO Geert van Gansewinkel said the peer-reviewed publication gives the company a clinical foundation for its next regulatory steps.

What's next: - AMT Medical is preparing CE marking for open and MIDCAB indications under the EU Medical Devices Regulation. - The company is preparing an Investigational Device Exemption submission to the U.S. Food and Drug Administration for an Early Feasibility Study. - Discussions are underway with several leading U.S. academic cardiac surgery centers. - AMT Medical plans next-generation trials in minimally invasive and robotic settings, including a multivessel study. - The company will continue two-year follow-up of the SAFE-CAB II patients. - AMT Medical also said it raised more than EUR 40 million to date, including a USD 25 million Series B in 2025.

The bottom line: - SAFE-CAB II gives AMT Medical its first peer-reviewed human evidence that a sutureless coronary bypass connector can be safe and effective, and it sets up the company’s push into larger trials and regulatory filings.