Medical devices (Auckland, N.Z.) · 2026
Preclinical Feasibility of the ELANA End-to-End Anastomotic Technique in a Porcine Pilot Study.
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Hoogewerf Marieke, Van Putte Bart P, Stecher David, Bergmann Wilhelmina, Klein Patrick, Doevendans Pieter A
Аннотация
PURPOSE: To advance minimally invasive surgical techniques, we developed the sutureless ELANA® End-to-End anastomotic technique. This preclinical study aimed to evaluate the technical feasibility, hemostatic performance, and short-term patency of the new approach in a porcine model.
METHODS: Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis.
RESULTS: The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15-45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology.
CONCLUSION: The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time.
METHODS: Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis.
RESULTS: The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15-45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology.
CONCLUSION: The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time.