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Biomatrix Flex found most resistant to deformation
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The Biomatrix Flex stent was the most resistant to deformation among six stents evaluated for susceptibility to distortion in a bench test.
John A. Ormiston, MD, of Mercy Angiography in Auckland, New Zealand, and researchers said adverse clinical events may arise from stent longitudinal distortion in some instances. The current analysis was a comparison of whether different stent designs were susceptible to distortion.
In the first bench comparison, force was applied to the entire circumference of the proximal stent hoop to gain a clearer understanding of stent design. The aim was to assess whether recommendations could be made for changes in design. The test for second-generation devices called for the application of force to a point on the proximal hoop of a malapposed stent, which the researchers suggested is more similar to clinical scenarios.
John A. Ormiston
There were six stent designs that underwent force and compression using a narrow rod. The investigators used an Instron device to apply force to the proximal hoop of five examples of each of the studied devices. They then measured distance compressed.
Results indicated that the pressure caused hoops on the side receiving the force to become pushed together. Malapposition occurred, as did obstruction of the lumen.
The proximal stent hoop also tilted. Lumen obstruction occurred along with malapposition on the contralateral side of the stent from where the force was applied.
Results of the second-generation test indicated that the Biomatrix Flex (Biosensors) was the device most resistant to deformation. The Element (Boston Scientific) was the most easily deformed device, according to the findings.
“The addition of more connectors between the proximal hoops in the Promus Premier (Boston Scientific) design has reduced the potential for distortion when compared with the Element, so that distortion was similar to the Vision (Abbott Vascular), Multi-Link 8 (Abbott Vascular) and Integrity (Medtronic) designs,” Ormiston and researchers concluded. “The test also provided insight into the way in which stents are likely to distort in clinical practice.”
Disclosure: Ormiston reports being an advisory board member for and receiving honoraria from Abbott Vascular and Boston Scientific. The other researchers report no relevant financial disclosures.
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