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  Flexia - Cobalt Chromium Coronary Stent System

Stent & balloon induced acute mechanical arterial injury during expansion is an importnat determinant of restenosis. The cellular signaling mechanism that result in platelet deposition, thrombus formation, & smooth muscle cell proliferation begin in response to arterial injury. It has been shown that deep injury to the media & superficial injury to the endothelium occur during stent expansion. Stent implantation imparts extreme vascular strain & focal mechanical injury to the vessel wall ranging from denudation of the endothelial cell mono layer, to progressive laceration of the deeper vascular structures. The amount of injury inflicted by the stent and balloon is a function of stent geometry.

Flexia coronary stent is the next generation Uniform sinusoidal cell geometry stent, designed to minimize stent induced arterial injury. It is carefully designed to incorporate controlled stent expansion charateristics, better stent-artery compliance, superior acute gain, optimum cell sizes & shape, lower strut thickness and high flexiblility. Flexia stent design enables uniform drug distribution throughout the stent length, thus serving as a best platform for drug eluting stent

 
Unique Design Features
Unique edge design offers controlled stent expansion.

Edge injuries are caused by both stent edge flaring during expansion & balloon "Dog Bonning". Conventional stent designs expand as "Edge First Expansion" resulting in injury at the edges. The stent balloon mismatch also causes injury at the edges due to "Dog Bonning" effect. Flexia incorporates wide closed cells at the stent edges that will minimize edge flaring & knife edge focal injury during expansion. Also the stent & balloon is precisely matched to minimize "Dog Bonning" effect.

 
Optimum cell size & shape

Generally during stent expansion, due to the intra cellular balloon protrusion, the expansion energy from the balloon is transferred to the arterial wall causing injuries. This is cell size & shape dependent. Flexia has optimum cell size & shape to minimize injuries.

Optimum cell size and shape
 
Lower strut thickness

Flexia has thin struts to minimize focal mechanical injury to the vessel wall.

FlexiaTM is Significantly Thinner Than Market Leading BMS
BMS Characteristics Liberte Driver ML Vision Flexia
 
Strut Thickness 132 µm 91 µm 81 µm 65 µm
Stent Material SS CoNi CoCr CoCr
Crossing Profile >1mm 1.1 mm <1mm <1mm
Strut thickness is just for graphical representation purpose - not scale
ML Vision is a brand of Abbott Vascular, Driver is brand of Medtronic, Liberte is brand of Boston Scientific.
 
Thin Strut Matters
Strut thickness has a significant impact on restenosis after stent implantation.
 
Better stent artery compliance

During the stent expansion, artery experiences exterme strain. Greater the strain greater is the injury. Flexia is designed to minimize arterial strain due to stent-artery compliance mismatch.

 
Superior acute gain-more vessel area

Because of more cell per diameter Flexia tends to recoil less than 4% when fully expanded, whereby offering Superior acute gain & more vessel area

 
High flexibility & lower crossing profile to address complex anatomies.

Lower strut thickness offers lower crossing profile & multi axial high flexibility while negotiating complex anatomies. Vessels do not tend to straighten after the stent expansion.

 
designed for optimal strength and flexibility
Accurate Surface Finish

Animal Studies (Histology and Histomorphometry) were carried out in juvenile domestic swine model at 7, 28 and 90 days. The results show that Re-endotheliazation was nearly completed at the end of 7 days and no significant differences in neointimal tissue proliferation was found in tested stents.

animal studies histology and histomorphometry
animal studies histology and histomorphometry
 
Illustrative Images of Optical Coherence Tomography

Time-point (days)

Vessel

Segment

Image

28

Left Circumflex

proximal

90

Left anterior  Desending

Distal

 
Technical Specification of Flexia L605 Cobalt Chromium Coronary Stent System
Available Stent Length (mm)

8, 13, 16, 19, 24, 29, 32, 37, 40

Available Stent Diameter (mm)

2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50

Stent Material

A medical grade L605 Cobalt Chromium alloy

Design

Uniform sinusoidal cell design

Recoil

< 4%

Stent Strut thickness

65 µm

Stent Strut Width

Proximal/Distal Cell: 85 µm Straight connector at proximal/Distal cell:  85 µm Mid Cell:  70 µm ‘U’ Connector:  50 µm

Balloon Delivery System

Rapid Exchange

Hydrophilic Coating On the distal and proximal shaft of balloon delivery system.
Delivery System Usable Length

140 cm

Balloon Inflation Pressure

Nominal Pressure (NP): 9 atm Rated Burst Pressure (RBP): 16 atm (RBP for 4.5mm-14 atm)

Guiding catheter Inner Diameter

5 Fr (0.056”) (1.4 mm) Compatible

Catheter Outer Shaft Diameter

2.70 Fr Proximally, 1.95 Fr Distally

Stent Length       

Crossing Profile

2.25 mm                

0.82 mm

2.50mm                 

0.85 mm

2.75mm                 

0.90 mm

3.00 mm               

1.00 mm

3.50 mm               

1.10 mm

4.00 mm               

1.16 mm

4.50 mm               

1.20 mm

Balloon Overhang

<0.5mm

Dogboning

<0.3mm

Delivery System Usable Length:

140 cm

Max. Guide wire

0.014 inch

Additional Brand Name of Flexia : CornetTM Cobalt Chromium Coronary Stent System
 
Ordering Information
Diameter
(mm)
8
13
16
19
24
29
32
37
40
2.25
FX2.2508
FX2.2513
FX2.2516
FX2.2519
FX2.2524
FX2.2529
FX2.2532
FX2.2537
FX2.2540
2.50
FX2.5008
FX2.5013
FX2.5016
FX2.5019
FX2.5024
FX2.5029
FX2.5032
FX2.5037
FX2.5040

2.75

FX2.7508
FX2.7513
FX2.7516
FX2.7519
FX2.7524
FX2.7529
FX2.7532
FX2.7537
FX2.7540
3.00
FX3.0008
FX3.0013
FX3.0016
FX3.0019
FX3.0024
FX3.0029
FX3.0032
FX3.0037
FX3.0040
3.50
FX3.5008
FX3.5013
FX3.5016
FX3.5019
FX3.5024
FX3.5029
FX3.5032
FX3.5037
FX3.5040
4.00
FX4.0008
FX4.0013
FX4.0016
FX4.0019
FX4.0024
FX4.0029
FX4.0032
FX4.0037
FX4.0040
4.50
FX4.5008
FX4.5013
FX4.5016
FX4.5019
FX4.5024
FX4.5029
FX4.5032
FX4.5037
FX4.5040
Indian FDA approved
Manufacturing License Number - G/28/1395
Download Brochure Download CE Certificate
 
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