InvoShield Emboli Protective Stent System is designed to provide an Emboli shower protection during and post stenting procedure. It is indicated to treat patients with coronary artery disease. It presents a novel combination of a coronary stent merged with an Emboli protective device. It is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent.
The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure. It provides long acting Emboli protection, without adding complexity in deliverability. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby may reduce injury and lower the likelihood of restenosis. It is based on a Cobalt Chromium (Co-Cr) L605 stent which is wrapped with an expandable, mesh. An InvoShield Stent is a novel thin-strut metallic stent with a PET net covering designed to trap and exclude thrombus and friable atheromatous debris to prevent distal embolization. The Net reduces the risk of plaque rupture and embolization providing double protection during and post procedure.
An InvoShield Emboli Protective Stent System is composed of cobalt chromium L605 stent which is CE approved, covered with a polymer sleeve knitted from micron level Poly Ethylene Terephthalate (PET) fiber pre mounted on a PTCA balloon catheter. An InvoShield Emboli Protective Stent System allows the secure transport of the stent through the coronary system. The stent can be positioned with X ray balloon markers in the desired stricture and applied via inflation of the balloon. The balloon inflates the steel covered with the flexible sleeve at nominal pressure to the nominal diameter.
|Available stent length (mm)||8, 13, 16, 19, 24, 29, 32 & 37|
|Available stent diameter (mm)||2.50, 2.75 (6 cell, 3 connectors) & 3.00, 3.50, & 4.00 (8 cell, 4 connectors)|
|Stent Material||A medical grade L605 Cobalt Chromium alloy|
|Stent Geometry||There are two models of cobalt chromium stent (with different length and diameter). The design pattern is similar in each model; however design pattern is remains same with different length of stents (from 8 to 37mm) in each model. 2.50-2.75 mm diameters Stent have six circumferential "cells" and three "connectors". 3.00-3.50-4.00 mm diameters Stent have eight circumferential "cells" and four "connectors".|
|Stent Strut thickness (mm)||65 µm|
|Stent Strut Width||Proximal/Distal Cell: 85 µm,
Straight connector at proximal/Distal cell: 85 µm, Mid Cell: 75 µm,
Connector: 50 µm
Rapid Exchange PTCA Balloon Delivery System
|Rapid Exchange PTCA Balloon Delivery System|
|Delivery System Usable Length||140cm|
|Hydrophilic Coating||On the distal shaft of balloon delivery system|
|Rapid Exchange Length||25cm|
|Markers on the proximal shaft||90cm and 100cm|
|Guiding Catheter Inner Diameter||5 Fr (0.056") Compatible|
|Maximum Recommended Guide wire||0.014" (0.36mm)|
|Balloon Inflation Pressure||Nominal Pressure (NP): 9atm
Rated Burst Pressure (RBP): 16atm*
.*RBP 14atm for 3.50x37mm, 4.00x32mm & 4.00x37mm Stents.
|Material||Poly Ethylene Terephthalate (PET)|
|Fiber Size||20 µm|
|Aperture Size at Expanded Stent||150 µm x 180 µm|