POSITIVE RESULTS

AMT Medical's sutureless bypass device hits 2.9% MACE at one year

SAFE-CAB II's one-year data show AMT Medical's ELANA system met its non-inferiority bar for device-related complications, setting up a bid for CE marking and a U.S. feasibility study.

By AppliedXLJuly 16, 2026Trial DRKS00020545

Executive Summary

A device designed to replace hand-sewn bypass connections met its safety bar in the first prospective human trial testing it, with patency results that improved in patients treated with the newest version of the device.
The finding comes from a single-arm study without a comparator arm, so the result establishes feasibility and safety rather than a head-to-head advantage over standard hand-sewn technique.
The sponsor is using the data to pursue CE marking for open and minimally invasive procedures and to seek a U.S. feasibility study, positioning the device as an enabler of less invasive and robotic bypass surgery rather than a novel therapeutic mechanism.
The hand-sewn step the device targets has remained largely unchanged for decades and is often cited as the technical barrier limiting adoption of minimally invasive bypass approaches, framing the readout's relevance beyond this cohort.

The readout

AMT Medical, a Dutch medical technology company, published one-year results from the SAFE-CAB II trial in The Journal of Thoracic and Cardiovascular Surgery on July 16, 2026. The trial enrolled 71 patients undergoing coronary artery bypass grafting and tested the ELANA Anastomotic System, a device that connects a bypass graft to a coronary artery using a titanium clip and a laser pulse instead of hand-sewn stitches. The trial recorded device-related major adverse cardiac events (MACE) in 2.9% of patients at one year, meeting the pre-specified non-inferiority threshold against a historical benchmark with a p-value of 0.0033. Six-month angiographic patency, whether the graft connection remained open, was 92.5% across the full study population and 97.5% in the subset treated with the latest-generation laser catheter. A

The design

SAFE-CAB II was a prospective single-arm trial, meaning every enrolled patient received the ELANA device and there was no concurrent group treated with conventional hand-sewn anastomosis. The 2.9% MACE rate was compared against a historical benchmark rather than a contemporaneous control arm, and the study analyzed 71 patients. A single-arm design of this size supports a safety and feasibility read, not a comparative efficacy claim against standard surgical technique. The trial registered under DRKS00020545 and is linked to NCT07005843. [DOC-1, DRKS00020545]

What the device does

Conventional CABG requires surgeons to hand-sew 8 to 12 stitches per graft connection, a step AMT Medical describes as the most skill-dependent part of the operation and the technical obstacle most often cited for limiting adoption of minimally invasive and robotic bypass procedures. The ELANA system forms the connection before the artery is opened, so blood flow continues throughout the procedure rather than requiring the artery to be clamped. AMT Medical frames the sutureless connection as a foundational step toward more standardized, less invasive bypass surgery, an application it is now pursuing through additional studies. A

Next steps

AMT Medical said it is preparing a CE marking submission covering both open and minimally invasive direct coronary artery bypass (MIDCAB) indications, alongside an Investigational Device Exemption (IDE) application to the FDA for a U.S. Early Feasibility Study. The company also plans next-generation trials in multivessel, minimally invasive, and robotic settings, and the SAFE-CAB II cohort continues in a two-year follow-up. Roughly one million CABG procedures are performed worldwide each year, the scale of the procedure volume the company is targeting with a device intended to standardize a step that has changed little since the 1960s. A

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