Unmet Clinical Need

• Large diabetic population with small vessels & diffused disease
• A dedicated small diameter, long DES.
• Once and done. Allows cost reduction.


Stent architecture

• Cobalt chromium (L605) platform with 65µm strut thickness.
• Hybrid cell design comprising of an intelligent mix of open and close cells resulting in excellent radial strength with a high flexibility.
• Unique strut width variability that ensure a <3% recoil and 0.29% foreshortening. • Special electro-polishing technique eliminates surface nickel oxides.


Low injury Design – Morphology Mediated ExpansionTM

• Conventional edge-flaring stent designs allow the stent to
dog-bone during deployment.
• This dog-boning coupled with balloon overhang may cause
edge injury.
• BioMime has struts with design variability which results in
morphology mediated expansionTM, having a propensity to
minimize stent edge injury.
• High fatigue resistance.
• High radial force.
• Excellent side branch access.
• Best in class crossing profile 0.033”.
• Enhanced delivery system for better Trackability, Pushability
and Torqueability.


Novel Drug Release Platform

• Biomime Aura DES uses a validated formulation of low dose sirolimus
(1.25 µg/mm²) times to elute in ~ 30 days from a biodegradable polymer
base which degrades simultaneously.

MeriStemTM

• Novel Shaft material for increased strength and kink resistance.

FeatherGlideTM

• Seamless catheter construction technology allows for exceptionally low
tracking force of 0.35N.
• Construction which generates high push transfer capability and reducing
the push forces to less than 0.08N.


Creative, colour coded spine labeling for easy retrieval from shelves

Technical Specification

Stent Details Stent Material Cobalt Chromium L605
Strut Thickness 65 µm (0.065mm or 0.0026”) For all Diameters
  Stent Design Hybrid cells – Close at edges, open at mid- segment
Stent Diameters 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 (mm)
  Stent Lengths 8, 13, 16, 19, 24, 29, 32, 37, 40, 44,48 (mm)
Mean 0.29% foreshortening
  Mean recoil 3%

Drug / Polymer Details Drug Sirolimus / Rapamycin
Drug loading 1.25µgm/mm2
Polymer BioPolyTM– Biocompatible /Biodegradable

Delivery System Details Delivery System Rapid Exchange
Stent Diameter (mm) Crossing Profile (mm / inches)
2.00 0.83mm / 0.033”
2.25 0.85mm / 0.033”
2.50 0.91 mm / 0.036”
2.75 0.98 mm / 0.039”
3.00 0.99 mm / 0.039”
3.50 1.06 mm / 0.042”
4.00 1.16 mm / 0.046”
4.50 1.19 mm / 0.047”
Nominal Pressure 9 ATM
Rated Burst Pressure 16 ATM
(14 ATM for diameter 2.50 mm, 2.75mm, 3.00mm with length 44mm and 48mm ; Diameter 3.50mm with lengths 37mm, 40mm, 44mm and 48mm; diameter 4.00mm with lengths 32mm, 37mm and 40mm; Diameter 4.50mm with all lengths available)
Balloon overhang <0.5mm
Shaft outer diameter Proximal 1.9F / Distal 2.7F
Radiopaque markers 2 – Platinum / Iridium
Usable Catheter length 140cms
Min. Guide Cath I.D. 5F / 0.065” (1.6mm)
Max. Guide Wire 0.014” (0.36mm)


Dia / Length 29mm 32mm 37mm 40mm 44mm 48mm
2.00mm
2.25mm BIA22529 BIA22532 BIA22537 BIA22540
2.50mm BIA25029 BIA25032 BIA25037 BIA25040 BIA25044 BIA25048
2.75mm BIA27529 BIA27532 BIA27537 BIA27540 BIA27544 BIA27548
3.00mm BIA30029 BIA30032 BIA30037 BIA30040 BIA30044 BIA30048
3.50mm BIA35029 BIA35032 BIA35037 BIA35040 BIA35044 BIA35048
4.00mm BIA40029 BIA40032 BIA40037 BIA40040
4.50mm BIA45029 BIA45032 BIA45037 BIA45040

Configurations

Dia / Length 8mm 13mm 16mm 19mm 24mm
2.00mm BIA20013 BIA20016 BIA20019 BIA20024
2.25mm BIA22508 BIA22513 BIA22516 BIA22519 BIA22524
2.50mm BIA25008 BIA25013 BIA25016 BIA25019 BIA25024
2.75mm BIA27508 BIA27513 BIA27516 BIA27519 BIA27524
3.00mm BIA30008 BIA30013 BIA30016 BIA30019 BIA30024
3.50mm BIA35008 BIA35013 BIA35016 BIA35019 BIA35024
4.00mm BIA40008 BIA40013 BIA40016 BIA40019 BIA40024
4.50mm BIA45008 BIA45013 BIA45016 BIA45019 BIA45024