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 Expansion^TM

• 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

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.

BioPoly^TM

• 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!

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 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	BioPoly^TM– 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

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“Meril” Biomime-Sirolimus Eluting Coronary Stent System