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.
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® 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|
The N-DEAVOUR® stent system has successfully passed the following clinical evaluation stages
N-DEAVOUR®s Everolimus Eluting Coronary Stent System comprises two components:
Cobalt-Chromium Bare Metal Stent
Rapid Exchange Semi Compliant Percutaneous Transluminal Angioplasty (PTCA) Balloon Catheter
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