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DESyne® NOVOLIMUS™ Eluting Coronary Stent System

The Path to Next Generation Drug-Eluting Stent Technology Engineered

to Maximize Deliverability and Clinical Performance.

Introducing the Novolimus-eluting DESyne stent - the next generation drug eluting stent with improved performance and superior clinical efficacy and safety1. Engineered on a clinically- proven cobalt chromium platform, the novel design and Formula X™ drug/polymer coating technology allows for thin struts, lowest polymer load2, and lowest drug concentration2 of any DES on the market today. DESyne® maximizes deliverability and is able to deliver superior performance with the lowest published late lumen loss4.

Stent Design

Cobalt Chromium Platform

The DESyne stent is manufactured on a clinically-proven cobalt chromium platform to maximize deliverability.

  • Lowest profile stent design with ultra-thin struts (81 microns) for high flexibility and deliverability
  • Substantial vessel wall coverage for uniform drug delivery and open cell design for ease of side branch access

Formula X™ Coating

Advanced Drug/Polymer Coating Technology

  • Thin polymer and drug matrix coating without the need for a primer coating
  • Superior DES clinical performance with excellent safety profile1

Lowest Polymer Coating Load2

  • Reduced risk of adverse clinical events1
  • Improved polymer biocompatibility3

Low Drug Dose

  • Sustainable performance with lower drug dose

Established Safety and Performance

  • Clinically proven ‘olimus’ drug family
  • Active metabolite of Sirolimus

Proprietary Drug Facilitates Superior Clinical Efficacy1

  • Potent anti-proliferative agent

Safety Profile

Elixir conducted five separate trials which included over 400 patients for the prevention of restenosis using DESyne and DEsyne BD stent systems resulting in excellent and sustained safety and effectiveness clinical outcomes.

Clinical Data

Elixir Medical has completed the EXCELLA First-in-Man trial and the EXCELLA II multi-center randomized trial for the DESyne Novolimus-Eluting Stent System.

In the EXCELLA study, the stent platform incorporated a proprietary durable polymer coating with an established safety profile designed to have a low polymer load and drug dose. Four and eight month angiographic late loss and IVUS analyses were completed. In addition clinical follow up has been successfully completed out to 5 years with excellent results. A stent platform that incorporated a proprietary biodegradable polymer coating designed to biodegrade within six to nine months, was also studied. Successful performance of these stents/coatings allowed the company to begin the EXCELLA II studies.

The EXCELLA II Trial was the CE-mark study which evaluated the DESyne® Novolimus Eluting Coronary Stent System compared to the Endeavor Zotarolimus Eluting Coronary Stent System in the treatment of up to two de novo native coronary artery lesions.

Learn more about EXCELLA II

 

 

1 » Serruys, P.W. et. al, EuroIntervention 2010.

2 » As compared to manufacturer reported thickness for Xience V® and Resolute®. Data on file at Elixir Medical.

3 » Data on file at Elixir Medical.

4 » As compared to manufacturer reported late lumen loss at follow up from similar trials. Data on file at Elixir Medical.

5 » SIRIUS: Weisz, G. et. al., JACC 2006 ; RESOLUTE: Serruys, P.W., EuroPCR 2009 ; SPIRIT III: Stone, G. W., Circulation 2009.