Biomime

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.
• 0.29% foreshortening
• 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.


Excellent Side Branch Access

• The area of the largest circle circumscribable in the cell of
the stent expanded to the nominal diameter: Tc = 0.71
mm2


Drug – Sirolimus

• Sirolimus acts on the common final pathway of cell division cycle without
exceptional risk of necrosis induction
• Low drug loading of 1.25µgm/mm2 of Sirolimus
• Drug elution time of 30 days.


BioPolyTM

• BioPoly is Meril’s propriety biodegradable co-polymer
formulation
• It offers uniformity in stent coating
• BioPoly Is highly stable during EtO process and there is no
loss in polymer integrity
• It does-not web, crack, lump on stent or balloon surface
• Exceptionally low coating thickness of <2µm is possible


BioMime Coating integrity

• Meril’s validated coating technique ensures uniformity of coating on both
abluminal and adluminal surfaces and around the stent edges



IT IS ONLY WHEN YOU HAVE A RESULT LIKE THESE!

SEM picture of BIOMIME endothelialisation

Complete and uniform endothelialisation, observed in porcine coronary artery model. At 28 or at 90 days, no significant differences were found in any histomorphometric parameters of lumen or neointimal hyperplasia (p > 0.05) between BIOMIME and Cypher in a pre-clinical porcine coronary artery model.

YOU WILL HAVE RESULTS LIKE THESE!


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 3.50 mm with length>35 mm;Diameter 4.00 mm with lengths >30 mm and Diameter 4.5mm with all lengths)
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)

Configurations

Dia / Length 8mm 13mm 16mm 19mm 24mm 29mm 32mm 37mm 40mm
2.50 mm BIO25008 BIO25013 BIO25016 BIO25019 BIO25024 BIO25029 BIO25032 BIO25037 BIO25040
2.75 mm BIO27508 BIO27513 BIO27516 BIO27519 BIO27524 BIO27529 BIO27532 BIO27537 BIO27540
3.00 mm BIO30008 BIO30013 BIO30016 BIO30019 BIO30024 BIO30029 BIO30032 BIO30037 BIO30040
3.50 mm BIO35008 BIO35013 BIO35016 BIO35019 BIO35024 BIO35029 BIO35032 BIO35037 BIO35040
4.00 mm BIO40008 BIO40013 BIO40016 BIO40019 BIO40024 BIO40029 BIO40032 BIO40037 BIO40040
4.50 mm BIO45008 BIO45013 BIO45016 BIO45019 BIO45024 BIO45029 BIO45032 BIO45037 BIO45040