AMT Medical Claims Positive Results for Heart Bypass Solution

The trial is now set to be expanded to include a further 65 patients by mid-2023.

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The preliminary results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass Solution have been unveiled.

AMT Medical announced that the 30-day post-operative outcomes of the open procedure showed 100% of patients to be free of Major Adverse Cardiovascular Events (MACE). In all cases there was no cardiac related mortality or myocard infarction, and no need to repeat the coronary revascularization.

This news marks an important landmark for the ELANA (Excimer Laser Assisted Non-Occlusive Anastomosis) Heart Bypass Solution and its developer, AMT Medical. The medical device could help facilitate the broader use of minimally invasive bypass surgery techniques. This in turn provides an alternative to traditional sutured (hand-sewed) CABG (Coronary Artery Bypass Grafting) surgery. If needed, the ELANA Heart Bypass Solution can also be used for CABG procedures.

The trial is now set to be expanded to include a further 65 patients by mid-2023.

"Having operated together on the first 10 patients, Dr. van Putte and I concluded that the ELANA Heart Bypass Solution proved to be safe and feasible in human application. We are now ready to go to the second stage of the SAFE-CAB trial to confirm these results in a broader range of patients with a longer follow-up - including graft patency assessment by coronary angiography after one year. These results will be used to achieve a European registration for the commercial use of this solution," said Drs. Klein.

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