AMT MedicalPrivate▲ Positive
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First-in-human trial shows safety and high patency, advancing the sutureless bypass system toward regulatory approvals.
AMT Medical announced that one-year results from the SAFE-CAB II trial of its ELANA Anastomotic System have been published in The Journal of Thoracic and Cardiovascular Surgery. The prospective, single-arm study enrolled 71 patients and met its primary endpoint, with device-related major adverse cardiac events occurring in just 2.9% of patients at one year, statistically non-inferior to the historical surgical benchmark. Six-month patency was 92.5% across the full trial and rose to 97.5% in the subgroup treated with the latest-generation laser catheter. The ELANA system replaces hand-sewing with a sutureless, laser-assisted technique that keeps the coronary artery open throughout surgery, and the company is now preparing for CE marking and an FDA Investigational Device Exemption submission.
First-in-human trial shows safety and high patency, advancing the sutureless bypass system toward regulatory approvals.