DESyne® BD Novolimus Eluting Coronary Stent System
The Elixir DESyne BD Novolimus-Eluting Coronary Stent System represents a significant advancement in biodegradable coating technology, eliminating the need for a primer coating and achieving a bare metal surface within 6 -9 months, while providing excellent DES results.
Stent Design
Cobalt Chromium Platform
The DESyne BD 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
Biodegradable Polymer Coating
Biodegradable Polymer Coating
- Ultra-thin biodegradable polymer dissolves within 6-9 months
- Trusted polylactide-based polymer
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 BD randomized trial for the DESyne BD Novolimus-Eluting Stent System.
The EXCELLA BD Trial was a randomized, prospective, multicenter, single-blind, non-inferiority study evaluating the DESyne® BD Novolimus Eluting Coronary Stent System (CSS) with resorbable polylactide-based polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System.
Learn more about EXCELLA BD
EXCELLA BD Randomized Clinical Study
OVERVIEW
The EXCELLA BD Trial was a randomized, prospective, multicenter, single-blind, non-inferiority study evaluating the DESyne® BD Novolimus Eluting Coronary Stent System (CSS) with resorbable polylactide-based polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System. The primary and principal secondary endpoints were: in-stent late lumen loss and a device-oriented composite endpoint (DoCE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target vessel revascularization (TLR).
- 146 patients enrolled at 10 sites world-wide
- Principal Investigators: Alexandre Abizaid, MD, PhD, Stefan Verheye, MD, PhD
- Clinical follow-up at 30 days, 6, 9, 12 months, and 2 – 5 years
- Angiographic and IVUS (sub-set of patients) follow-up at 6 months
- Primary endpoint: in-stent late lumen loss
- If non-inferiority was met, then tested for superiority
- Available stent sizes: 2.5, 3.0 and 3.5mm diameters in lengths of 14, 18 and 28mm
- Drug dose – 5mcg per mm of stent length
- Polymer bioabsorption rate: 6 – 9 months
RESULTS
The DESyne®BD stent was shown to be not only non-inferior (p<0.001) but also superior (p< 0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.12±0.17 vs. 0.67±0.47, p < 0.001). IVUS results mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction for the DESyne stent versus the Endeavor stent (3.6 ±4.2% vs. 20.7±14.2, p<0.001). Clinical event rates through six months were low and similar for both groups (DoCE – 2.7% vs. 3.2%, p=1.00), DESyne vs. Endeavor).
CONCLUSIONS
In the EXCELLA BD randomized clinical trial, the DESyne® BD Novolimus Eluting Coronary Stent System with resorbable polymer demonstrated superior results to the control Endeavor stent for the primary endpoint of in-stent late lumen loss. Clinical event rates are low demonstrating the safety of the DESyne BD stent.
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.
