beStent--the serpentine balloon expandable stent: review of mechanical properties and clinical experience.
The objective of this study was to present the engineering and clinical aspects of a new balloon expandable coronary stent. A new tubular, serpentine design stainless steel balloon-expandable stent, the beStent, was designed based on clinical requirements for stents and has been clinically evaluated in multiple sites. The stent is featured by terminal gold markers and rotational junctions that assure no shortening upon expansion and lead to orthogonal locking, maximizing radial strength. In terms of methods and results, the stent was clinically evaluated in the framework of a pilot evaluation in a variety of lesion types. The short- and long-term results evaluated during the course of the beStent multicenter pilot evaluation and in our single center study are reported. A variety of patients were included, including patients with long complex lesions, restenosis lesions, and total occlusions. Short-term clinical success with stenting was achieved in more than 97% of the cases. Subacute thrombosis was low in 1% of the cases. Clinical restenosis rates were acceptable with an overall 85% 6 month event free survival. In conclusion, the mechanical features of the stent providing its flexibility, scaffolding properties, radial strength, and absence of shortening were tested in a clinical study, showing that it is safe and effective for treating simple as well as long and complex lesions associated with coronary disease with a relatively low rate of complications.
Roguin
A
A
Division of Invasive Cardiology, Rambam Medical Center, Technion-Israel Institute of Technology, Haifa.
Beyar
R
R
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000601:surgery*; D018572:Disease-Free Survival; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019919:Prosthesis Implantation; D012042:Registries; D015607:Stents; D016896:Treatment Outcome