BIODEGRADABLE PERIPHERAL IGAKI-TAMAI STENTS
…PERSEUS“ STUDIES
G.Biamino
University of Leipzig – Heart Center Department of Clinical and Interventional Angiology
Leipzig, Germany
Rationale for Biodegradable Stents
Rationale for Biodegradable Stents Concerns
THE NEW
NIGHTMARE
In SFA
Stent fractures and
In-stent restenoses
Rationale for Biodegradable Stents
IGAKI - TAMAI STENT Biodegradable Peripheral Stent
Compatible
MRI Non Ferromagnetism
Proximal and distal edges Stent of radio-opaque markers
Excellent Longitudinal flexibility
21.17% (at 5mm), 17.69%(at 6mm),17.22% (at 7mm), 15.27%(at 8mm)Polymer surface area (expanded)
< 1.6% (at 5mm), < 1.9%(at 6mm),< 3.2%(at 7mm), < 3.7%(at 8mm)Percentage shortening on expansion
0.68mm 2Polymer cross-sectional area
(expanded)
7mm(stent type at 5mm and 6mm) 9mm(stent type at 7mm and 8mm)Expansion range
5.0,
6.0,
7.0,
8.0 mm Available diameter
36mm Available length
0.24 mm(0.009inch)Strut thickness
Zig zag herical coil Stent design
PLLA(poly-L-lactic acid) medical grade Material composition
Stent Specification
Peripheral Stent Delivery System 8F 60cm
60cm 8F
6.0,
7.0,
8.0 mm
Balloon size: 4 cm (Stent lenth 36 mm)Balloon length:
60 cm and 120 cm System length:
Outer diameter; 8F Protective sheat:
PERSEUS- Study design
Max. 2 stents were permitted, limiting
6 - 7
the length of the lesion to cm
PERSEUS- Study Objectives
PERSEUS- Study Endpoints
PERSEUS- Study Endpoints
PERSEUS- Study Population ?N = 103 patients scheduled for PTA St. IIb
G.H.1
G.H.2
G.H.3
G.H.5
PERSEUS- Study Results
Pre Intra
Post