NIRxcell™, our fifth generation coronary stent, showed outstanding results in numerous clinical trials involving more than 750 patients. The NIRxcell™ bare metal stent was designed for superior deliverability and conformability and features Medinol’s patented WiZeCell™ stent design. 

 

 

  • Multi center, post market, non-randomized, prospective, single arm clinical study evaluating the safety and effectiveness of NIRxcell stent
  • 278 patients enrolled at 16 sites from Europe and Israel
  • De novo stenotic lesions in native coronary arteries
  • Primary endpoint: TVF at 270 days
  • Result: TVF at 270 days was 8.7% (significantly lower than the performance goal of 16.5%) 

 

 

  • Multi-center, post-market surveillance registry evaluating the performance and long term safety of the NIRxcell stent
  • 318 patients enrolled in Spain and Portugal
  • De novo native coronary artery lesions 
  • Primary endpoint: composite of MACE (cardiac death, MI and clinically-driven TLR) at 12 months
  • Result: MACE at 12 months was 2.9% (significantly lower than the performance goal of 15.0%) and clinically-driven TLR rate at 12 months was 1.6%

 

  • A non-randomized single arm registry, evaluating the safety of NIRxcell Stent 
  • 101 patients enrolled in Belgium and Luxembourg
  • De novo stenotic lesions in native coronary arteries
  • Primary endpoint: composite of MACE (cardiac death, MI and clinically-driven TLR) at 30 days and 6 months
  • Result: MACE at 30 days was 0 and at the 6-12 months period it was 7.9% 

 

 

*PIONIR – Hoffmann S. Eurointerventions. 2011 May; Volume 7 (the NIRxcell stent is identical to the stent used on the PIONIR study). Endeavor II Trial; Endeavor vs. Driver Stent: Fajadet et al., Circ. 2006; 114:798-806. OMEGA Trial, John C. Wang, MD, CRT 2014. Multi-Link Vision Registry; Kereiakes et al., Am J Cardiol. 2003; 92:463-6

**PIONIR – Hoffmann S. Eurointerventions. 2011 May; Volume 7 (the NIRxcell stent is identical to the stent used on the PIONIR study). The Iberian and Belgian Registries – Data on file at Medinol.

Accordion Title: 
EluNIR Trials
NIRTRAKS
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