“Meril” Biomime-Sirolimus Eluting Coronary Stent System


Brief:“Meril” Biomime-Sirolimus Eluting Coronary Stent System

Modified:2017-08-09

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

Hybrid Cell Design


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.

Morphology Mediated Expansion


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

Side Branch Access


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.

Sirolimus

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

BioPoly

BioMime Coating integrity

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

Coating integrity

Biomime

IT IS ONLY WHEN YOU HAVE A RESULT LIKE THESE!

Clinical Study

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 MaterialCobalt Chromium L605
Strut Thickness65 µm (0.065mm or 0.0026”) For all Diameters
Stent DesignHybrid cells – Close at edges, open at mid- segment
Stent Diameters2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 (mm)
Stent Lengths8, 13, 16, 19, 24, 29, 32, 37, 40, 44,48 (mm)
Mean0.29% foreshortening
Mean recoil3%

Drug / Polymer DetailsDrugSirolimus / Rapamycin
Drug loading1.25µgm/mm2
PolymerBioPolyTM– Biocompatible /Biodegradable

Delivery System DetailsDelivery SystemRapid Exchange
Stent Diameter (mm)Crossing Profile (mm / inches)
2.000.83mm / 0.033”
2.250.85mm / 0.033”
2.500.91 mm / 0.036”
2.750.98 mm / 0.039”
3.000.99 mm / 0.039”
3.501.06 mm / 0.042”
4.001.16 mm / 0.046”
4.501.19 mm / 0.047”
Nominal Pressure9 ATM
Rated Burst Pressure16 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 diameterProximal 1.9F / Distal 2.7F
Radiopaque markers2 – Platinum / Iridium
Usable Catheter length140cms
Min. Guide Cath I.D.5F / 0.065” (1.6mm)
Max. Guide Wire0.014” (0.36mm)

Configurations

Dia / Length8mm13mm16mm19mm24mm29mm32mm37mm40mm
2.50 mmBIO25008BIO25013BIO25016BIO25019BIO25024BIO25029BIO25032BIO25037BIO25040
2.75 mmBIO27508BIO27513BIO27516BIO27519BIO27524BIO27529BIO27532BIO27537BIO27540
3.00 mmBIO30008BIO30013BIO30016BIO30019BIO30024BIO30029BIO30032BIO30037BIO30040
3.50 mmBIO35008BIO35013BIO35016BIO35019BIO35024BIO35029BIO35032BIO35037BIO35040
4.00 mmBIO40008BIO40013BIO40016BIO40019BIO40024BIO40029BIO40032BIO40037BIO40040
4.50 mmBIO45008BIO45013BIO45016BIO45019BIO45024BIO45029BIO45032BIO45037BIO45040



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