CORONARY INTERVENTION - INVOSHIELD
InvoShield - Emboli Protective Stent System
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. InvoShield Emboli Protective Stent System presents a novel combination of a coronary stent merged with an Emboli protective device. InvoShield Emboli protective device 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. InvoShield Emboli Protective Stent System 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. InvoShield Emboli Protective Stent System is based on a Cobalt Chromium (Co-Cr) L605 stent which is wrapped with an expandable, mesh. An InvoShield Stent (EPS) 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.

Device Description:

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.
 

Table: 1 Device Component Description:

Stent
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
Balloon Material Polyamide
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.
Net
Material Poly Ethylene Terephthalate (PET)
Fiber Size 20 µm
Aperture Size at Expanded Stent 150 µm x 180 µm
 

Indications:

An Emboli Protective Stent System is indicated for improving luminal diameter in vessels with reference diameter from 2.50 to 4.00 mm having lesion length < 37 mm and providing Emboli protection in the following cases:
Symptomatic coronary artery disease due to discrete de novo or restenosis lesion in native coronary artery
Symptomatic coronary artery disease due to culprit lesion in saphenous vein graft
Treatment of coronary lesion in patients undergoing primary or rescue PCI for acute ST-segment elevation myocardial infarction (STEMI)
Treatment of coronary lesion having atherothrombotic appearance in patients with not ST-elevation acute coronary syndromes (unstable angina and non ST-segment elevation myocardial infarction)

Unique Design Features of InvoShield Emboli Protective Stent System:

InvoShield is suitable for acute coronary syndromes and particularly acute MI as the net reduces embolization and enables excellent myocardial blush and flow.
It prevents plaque dislodgement and blocks debris from entering the bloodstream during and post procedure (called embolic showers)
Exceptional technology of PET mesh wrapped around cobalt chromium stent helps to diffuse the stent pressure and reduces injury to the vessel
InvoShield Stent structure is engineered for outstanding flexibility and conformability.
Circumferential closed cells design with multiple connectors for uniform expansion.
Optimum cell size and shape result in minimum vessel wall injury due to intra cellular balloon protrusion.
Better vessel wall coverage
No plaque protrusion
Lower strut thickness to minimize focal mechanical injury to endothelium and media
Optimal thickness of stent strut provides favorable balance between radial strength and deliverability
Better crossing profile
Better stent artery compliance to minimize arterial strain due stent artery compliance mismatch
Alternate "U" connectors offer excellent flexibility and exceptional deliverability.
InvoShield deploy typically as the balloon expandable stent, deliverability and crossing profile remain the same and dilatation pressure is not affected.
 

InvoShield Highlights:

Prevent distal embolization
Stabilize ruptured plaque
Improve safety outcome
Maintain Standard stenting procedure
No learning curve
Best in deliverability

Advantages of the New Concept:-

Flexible structure
Minimal foreign body reaction
Does not promote thrombosis
 
InvoShield — A medical grade cobalt chromium CE approved stent and emboli protective device merged into one
InvoShield — An expandable, flexible fishnet style, micron level knit sleeve that wraps the stent
InvoShield — blocks debris from entering the blood stream during and post PTCA procedure
InvoShield — may lower restenosis rate by reducing injury to the arterial wall InvoShield — designed to reduce thrombosis
InvoShield — maintains simple deliverability
  Download Brochure
Indian FDA approved
Manufacturing License Number - G/28/1395
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All rights reserved by Nano Therapeutics Pvt Ltd @ 2014