Lexington’s AEON Endostapler reaches 10,000 procedure milestone



Lexington Medical has announced that the company has achieved over 10,000 successful surgeries with the AEON Endostapler for multiple specialties across multiple countries. According to the company, the AEON Endostapler is clinically proven to deliver better staple formation as shown in tens of thousands of staple lines and uniquely addresses the challenges of variable tissue types in critical procedures including bariatric, thoracic, colorectal and hepatobiliary surgeries.1 AEON has been adopted by key global opinion leaders as their preferred stapler for its excellent performance, surgical precision, and patented technologies including the advanced reload architecture, multi-speed firing gear and smooth articulation.

Recent findings from a randomised clinical trial demonstrated that AEON produces a significantly drier staple line outperforming another surgical stapling device and is associated with a 20% reduction in interventional bleeding control. In this peer-reviewed, blinded study, 'Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler', published in the JSLS (2020 Oct-Dec;24(4):e2020.00073), the Journal of the Society of Laparoscopic & Robotic Surgeons, the investigators also reported consistent satisfaction with AEON staple lines.

In total, 60S consecutive laparoscopic sleeve gastrectomy procedures were performed by three surgeons; 30 sleeves using the AEON Endostapler on thick mode and 30 using the Echelon Flex Powered Stapler with pulse technique. Stapler performance was measured by incidence and degree of staple line bleeding. Images of the first firing and fundus were taken with the laparoscope ten seconds after the final firing. Images were evaluated by a third-party blinded evaluator and given a "bleeding score," a qualitative measure of intra-operative staple-line bleeding (1=no bleeding to 5=profuse bleeding).

The outcomes showed that the AEON Endostapler demonstrated a lower mean (± standard error) "bleeding score" versus the Echelon Flex™ (2.1 ± 0.1 vs. 2.6 ± 0.1; p=0.01). The AEON Endostapler had 15 cases (50%) with no bleeding at the fundus; the Echelon Flex had seven cases (23%) with no bleeding at the fundus. The AEON Endostapler had 0 cases (0%) with profuse bleeding; the Echelon Flex had 2 cases (7%) with profuse bleeding.

“We are pleased to reach this exciting milestone for our AEON surgical stapling devices,” said Leon Amariglio, Founder and Chief Executive Officer, Lexington Medical. “As Lexington Medical is dedicated to providing surgeons with high quality stapling solutions, we look forward to further expanding our global reach and benefiting more patients across the world. We thank all of the surgeons and partners who have travelled this journey with us and helped achieve this significant milestone.”

Reference

1) Data on file.