Call for standards in technical documentation of intracoronary stents.
At present, the product information of intracoronary stents provided by the industry contains only limited technical data restricting judgments on the in vivo performance of individual products. Available experimental and clinical evidence suggests that interventional target sites display highly heterogeneous biomechanical behavior needed to be matched by specific stent and stent delivery system characteristics. To allow individualized stent-lesion matching, both, understanding of biomechanical properties of the atherosclerotic coronary artery lesions and expert knowledge of the intracoronary stent systems, are required. Here, the authors review some of the initial data on mechanical properties of coronary artery lesions potentially relevant to stenting and suggest standards for technical documentation of intracoronary stents.
Department of Medicine, Gesundheitszentrum Bitterfeld/Wolfen gGmbH, Erlagen, Germany. planzer@gzbiwo.de
Peter
P
Lanzer
Frank J H
FJ
Gijsen
L D Timmie
LD
Topoleski
Gerhard A
GA
Holzapfel
D015906:Angioplasty, Balloon, Coronary / Q000592:standards*; D001696:Biomechanical Phenomena; D003324:Coronary Artery Disease / Q000628:therapy*; D004282:Documentation / Q000592:standards*; D004869:Equipment Safety / Q000592:standards; D006801:Humans; D011356:Product Labeling / Q000592:standards; D011474:Prosthesis Design / Q000592:standards; D015607:Stents / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000706:statistics & numerical data