Flexia - Cobalt Chromium Coronary Stent System
Stent & balloon induced acute mechanical arterial injury during expansion is an important determinant of restenosis. The cellular signaling mechanisms 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 monolayer, 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 characteristics, better stent-artery compliance, superior acute gain, optimum cell sizes & shape, lower strut thickness and high flexibility. Flexia stent design enables uniform drug distribution throughout the stent length, thus serving as a best platform for drug eluting stent.
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.
Edge injuries are caused by both stent edge flaring during expansion & balloon "Dog Boning". 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 Boning" 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 Boning" effect.
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.
Flexia has thin struts to minimize focal mechanical injury to the vessel wall. It is Significantly Thinner Than Market Leading BMS.
Strut thickness has a significant impact on restenosis after stent implantation.
During the stent expansion, artery experiences extreme strain. Greater the strain greater is the injury. Flexia is designed to minimize arterial strain due to stent-artery compliance mismatch.
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.
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|
|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’|
|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|
|3.00 mm||1.00 mm|
|3.50 mm||1.10 mm|
|4.00 mm||1.16 mm|
|4.50 mm||1.20 mm|
|Delivery System Usable Length:||140 cm|
|Max. Guide wire||0.014 inch|