Proudly continuing its legacy of innovation, Medinol presents EluNIR™, the first ever elastomer Drug-Eluting Stent. Combining the clinically proven NIRxcell™ stent platform with a unique elastomer coating and Limus-family drug, EluNIR has demonstrated excellent results in two randomized clinical trials including more than 2,200 patients treated in the United States, Canada, Europe and Israel.

 

Target Lesion Failure (TLF) at 12 Months

 

Stent Thrombosis at 12 Months

For more data on the EluNIR trials

 

  • We developed eDES™ (elastomer Drug-Eluting Stent) coating in response to concerns over stents coated with durable and biodegradable polymers that are inherently brittle 
  • Drug-Eluting Stents coated with brittle polymers suffer from surface imperfections that can lead to cracking and peeling of the polymer coating. This has been observed directly "out-of-the-box" (crimping deformations), after deployment or drug elution, or during side branch expansion

Cracking and Peeling of "Brittle" Durable and Biodegradable Polymer in Various DES

 

  • Cracking and peeling of a brittle polymer coating could lead to inflammatory reactions and may contribute to restenosis or thrombosis. Surface imperfections may also result in uneven drug release by under and over-dosing of the vessel wall 
  • The elastomeric coating was designed to eliminate irregularities and deformations in the stent surface and results in a smooth and uniform stent surface that ensures comprehensive and controlled drug elution

 

eDES: Smooth and Uniform Elastomer Coating Before and After Expansion

 

  • Unmatched Ease-Of-Delivery -EluNIR owes its deliverability to Flexx², our catheter technology with an innovative spring tip that is more pushable and at the same time more flexible than plastic tips used in other delivery systems
  • Low True Entry-Profile - The spring tip was designed to cross difficult lesions, traverse implanted stents and tackle tortuous and calcified anatomies 
  • The Only Visible Tip – The only DES with a radiopaque tip, enabling visualization of the catheter-tip location during PCI

 

radio opaque spring tip visible in xray angioplasty

                         Superior Deliverability - the Spring Tip                                                      A Visible Tip

 

  • Best In Class Vessel Conformability and Scaffolding – WiZeCell, the clinically proven design of our NIRxcell™ stent minimizes variations in cell size, providing a high conformability in curved sections and uniform scaffolding even during myocardial contractions
  • Low Crossing Profile and excellent flexibility during delivery
  • Optimal side-branch access after stent deployment
  • WiZeCell and eDES coating facilitate uniform release of drug into the vessel wall

                                   WiZeCell Stent Design - Best In Class Conformability and Scaffolding

  • Avoiding Snap Trap Effect - Unlike other stent designs, WiZeCell does not allow large gaps between struts and minimizes the Snap Trap Effect that may lead to tissue prolapse and potentially inflammatory processes and restenosis
  • Medinol’s unique patented manufacturing technology, ensures a more precisely produced stent and markedly-enhanced quality control
  • EluNIR stents are laser-cut from cobalt-chromium alloy panels. The stent panels then undergo Automated Visual Inspection (AVI) on both the luminal and abluminal surfaces and are coated with an elastomer and Limus-family drug
  • QualitySurface is the only technology that currently enables coating stents with an elastomer, providing EluNIR with smooth and uniform surface that ensures comprehensive and controlled drug elution

 

                            QualitySurface Manufacturing                                      EluNIR Coating at Work  

 

 

The EluNIR Stent, formerly known as BioNIR, is the stent used in the BIONICS and NIREUS Trials.

EluNIR is not approved for marketing

Accordion Title: 
EluNIR Trials
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