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Nano Therapeutics Pvt. Ltd. - Heart Stent Manufacturing Company Surat, India
Nano Therapeutics Pvt. Ltd. - Heart Stent Manufacturing Company Surat, India

Emboli Protective Stent System

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.

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.

Device Description - InvoShield - Nano Therapeutics Pvt. Ltd. - Heart Stent Manufacturing Company Surat, India
Device Component Description
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.
Material Poly Ethylene Terephthalate (PET)
Fiber Size 20 µm
Aperture Size at Expanded Stent 150 µm x 180 µm
Unique Design Features
  • 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