3V NEIL

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Sirolimus Drug Eluting Stent System

Worldwide, Drug Eluting Stents were introduced in order to counter the high restenosis rates associated with Bare Metal Stents. 3V NEIL Sirolimus Eluting Stent System elutes Sirolimus from a biodegradable polymer matrix. The drug is coated on both abluminal and luminal surfaces of the stent and is released in a controlled manner. This gives the device Superior safety and efficacy.

How it works

Release:

90% of the Sirolimus is released in 4-6 weeks

  • Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile & has a melting temperature of approximately 183-185 ºC. Sirolimus belongs to a class of therapeutic agents known as macro cyclic lactones or macrolides. It is a cytostatic drug and an immunosuppressant.
  • It inhibits cell motility by suppression of m-TOR mediated 56K1 and 4E-BP1 pathways.
  • It inhibits T-Lymphocyte activation and proliferation occurring in response to antigen and cytokine. It also inhibits antibody production. It demonstrates anti proliferative activities.
  • The drug content on 3V NEIL Sirolimus Eluting Coronary Stent ranges between 34 micrograms to 412 micrograms. The coating concentration is 1.4 microgram/ sq.mm

Product Design

3V Neil is a state of the art Sirolimus Eluting Stent System based on a Cobalt Chromium stent platform, which elutes the drug, Sirolimus (C51H79NO13) from a bio degradable polymer over a period of 4-6 weeks.

The drug coating of 3V Neil stent System consists of the drug, Sirolimus (the active ingredient) and bio degradable polymer (the inactive ingredient), coated on the entire surface of the cobalt chromium stent at a dose of approximately 1.4 µg/mm2.

The bio degradable polymer is a combination of Poly lactic acid (PLA) and Poly-lactic-co-glycolic acid (PLGA) which is completely metabolized in the body (breaking down into monomers, water and carbon dioxide).

A unique spray coating technology offers uniformity of coating without any coating defects and maintains its integrity in in-vitro tortuous path.

Crimped stent

 

Stent Dog Boning

Product Benefits

  • Excellent stent apposition as evidenced in OCT, with a score of less than 20 microns.
  • Coated with highly effective anti profiliferative drug -Sirolimus
  • Rapid breakdown of bio degradable polymer to enhance early vascular healing and quick endothelialisation.

Technical Specifications

Stent Material Cobalt Chromium L605
Strut Thickness (µm) 73
Drug Sirolimus
Polymer PLA/PLGA
Loading dose 1.4 micro gm/sq mm
Drug Elution 90% in 4-6 weeks
Crossing Profile (mm.):
  • 2.25mm diameter
  • 2.50 mm diameter
  • 3.00 mm diameter
  • 3.50 mm diameter
  • 4.00 mm diameter
0.87+- 0.05
0.90 +- 0.05
0.95+-0.05
1.02 + - 0.06
1.10 + - 0.08
Stent Diameters (mm) 2.25 - 4.00
StentLengths (mm) 8- 40
Average Foreshortening (%) < 10%
Average Recoil < 7%
Guide Catheter Compatibility (Fr):
  • 2.25 - 4.00 mm
5
Nominal Pressure (bar) 8
Rated Burst Pressure (bar):
  • 4.0mm (diameter) with lengths > 20mm
  • 4.0mm (diameter) with lengths ≤ 20mm
  • Balloons below 4mm (diameter)


14
16
16

 

Ordering Information

Length in mmDiameter in mm
2.252.502.753.003.504.00
8 mm N108 N208 N308 N408 N508 N608
12 mm N112 N212 N312 N412 N512 N612
16 mm N116 N216 N316 N416 N516 N616
20 mm N120 N220 N320 N420 N520 N620
24 mm N124 N224 N324 N424 N524 N624
28 mm N128 N228 N328 N428 N528 N628
32 mm N132 N232 N332 N432 N532 N632
36 mm N136 N236 N336 N436 N536 N636
38 mm N138 N238 N338 N438 N538 N638
40 mm N140 N240 N340 N440 N540 N640

 

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