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N-DEAVOUR®, produced by N-ovative Health Technologies (NHT), is Pakistan’s first Drug Eluting Coronary Stent System which prevents the recurrence of late stent restinosis. The drug in the mechanism is released in a controlled manner over time to not only save the coronary artery from future blockade, which is the mechanical function of a stent, but also from unhealthy cell growth as a response, which has been experienced widely by patients who implant a Bare Metal Stent.

Key Features
  • Everolimus Eluting Stent
    • - Hydrophilic coated distal shaft
      - Superior trackability
      - Low lesion entry profile
  • Excellent biocompatibility
  • Optimum durability
  • Durable polymer coating technology
  • Low In-Stent Restenosis (ISR) Rate
  • Optimal healing
  • Efficient re-endothelialisation
Technical Details

N-DEAVOUR® is a combination product comprised of two key components: the stent (which includes a base coat of Poly Butyl Methacrylate (PBMA) and a top coat of PVDF-HFP (non-erodable polymer) and the active pharmaceutical ingredient Everolimus.

N-DEAVOUR® has an MP35NLT Cobalt-Chromium (major elements include Cobalt, Nickel, and Chromium) stent platform and is pre-mounted on a PTCA Balloon Dilatation Catheter

Everolimus is the active pharmaceutical ingredient in the N-DEAVOUR® stent. It is a semisynthetic macrolide immunosuppressant, synthesised by chemical modification of rapamycin (sirolimus). Drug content is 100µg/cm² Everolimus per/mm². The drug load is 100 μg/cm2 for all product sizes. The drug load is 100 μg/cm2 for all product sizes.

N-DEAVOUR® stent contains inactive ingredients including Poly N-Butyl Methacrylate (PBMA), a polymer that adheres to the stent and drug coating, and PVDF-HFP, which is comprised of vinylidene fluoride and hexafluoropropylene monomers as the drug matrix layer containing Everolimus.

PBMA is a homopolymer with a molecular weight (Mw) of 264,000 to 376,000 dalton. PVDF-HFP is a non-erodible semi-crystalline random copolymer with a molecular weight (Mw) of 254,000 to 293,000 dalton. The drug matrix copolymer is mixed with Everolimus (83%/17% w/w polymer/Everolimus ratio) and applied to the entire PBMA coated stent surface.

N-DEAVOUR Technical and Performance Specifications

N-Deavour® Size/ Everolimus Content
Stent Length Everolimus Content
12 mm 51.87 µg
16 mm 67.41 µg
22 mm 93.36 µg
26 mm 108.93 µg
30 mm 124.47 µg
N-DEAVOUR® Stent System Catalogue
Balloon Catheter Diameter (mm) 8 12 16 18 22 26 30
2.00 A18008 / B20012 A18012 / B20016 A18016 / B20020 A18018 / B20022 A18022 / B20026 A18026 / B20030 A18030 / B20034
2.50 A18008 / B25012 A18012 / B25016 A18016 / B25020 A18018 / B25022 A18022 / B25026 A18026 / B25030 A18030 / B25034
3.00 A18008 / B30012 A18012 / B30016 A18016 / B30020 A18018 / B30022 A18022 / B30026 A18026 / B30030 A18030 / B30034
3.50 A18008 / B35012 A18012 / B35016 A18016 / B35020 A18018 / B35022 A18022 / B35026 A18026 / B35030 A18030 / B35034
4.00 A18008 / B40012 A18012 / B40016 A18016 / B40020 A18018 / B40022 A18022 / B40026 A18026 / B40030 A18030 / B40034
CE Certification is in process
Product Readiness

The N-DEAVOUR® stent system has successfully passed the following clinical evaluation stages

  1. Physico-Chemical Testing (ISO 25539) – conducted at Heinz Schade, GmbH, Germany
  2. Animal trials – conducted at American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland
  3. Human trials –In progress - in coordination with top scientists at Emory University, Atlanta, Georgia, USA
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Product Illustrations

N-DEAVOUR®s Everolimus Eluting Coronary Stent System comprises two components:

Cardiovascular Implant

Cobalt-Chromium Bare Metal Stent

Cardiovascular
Delivery System

Rapid Exchange Semi Compliant Percutaneous Transluminal Angioplasty (PTCA) Balloon Catheter

delivery-system
Stent is mounted (crimped) on balloon portion of catheter
diagram
  • Gauge length of balloon is always kept 2±0.5 mm larger than the total length of stent.
  • Length of stent has a tolerance of ±0.5mm.
  • X-ray marker is placed inside the edge of gauge length of balloon, X-ray marker’s width is 1±0.25 mm.
  • Stent is placed in between two X-ray markers; distance from edge to edge of stent and X-ray marker is 1±0.5mm on each side.
Product Standard Compliance

N-DEAVOUR® stent is manufactured using biocompatible materials in compliance with EN ISO 10993-1 and is safe and compatible to Magnetic Resonance Imaging (MRI) environment in compliance with ASTM F2503, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213.


N-DEAVOUR® stent has the ability to access and accurately deploy in coronary artery with fixation effectiveness keeping stent integrity with appropriate sizing to maintain luminal patency and improve luminal diameter of artery with minimum haemostasis, having ability of easy withdrawal in compliance with EN ISO 14630 and DIN EN ISO 25539-2

Copyright 2020 | All Rights Reserved
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