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DESyne Novolimus Eluting Coronary Stent System
DESyne Novolimus Eluting Coronary Stent System
The document introduces the Novolimus-eluting DESyne® stent, a next-generation drug-eluting stent designed for improved performance and clinical efficacy. It is built on a cobalt chromium platform with a novel design and Formula X™ drug/polymer coating technology, featuring thin struts, low polymer load, and low drug concentration.
Specifications
The stent system is engineered for maximum deliverability and clinical performance. It includes a unique drug agent with advanced drug/polymer coating technology, offering a thin polymer and drug matrix coating without a primer. The system boasts the lowest polymer coating load, reducing the risk of adverse clinical events and improving biocompatibility. The proprietary Novolimus drug elution is a potent anti-proliferative agent with a known safety profile.
Clinical Performance
The DESyne® stent demonstrates significant clinical performance improvements, including a reduction in late lumen loss and major adverse cardiac events (MACE). Comparative trial results show a 61% reduction in MACE and a 74% reduction in clinically induced target lesion revascularization (CI-TLR). The stent also shows optimal neointimal coverage with low neointimal volume obstruction.
Clinical Trials
Data from the EXCELLA II trial indicates an 82% reduction in late lumen loss and a 78% reduction in neointimal volume obstruction. The stent's performance is compared against other stents like ENDEAVOR®, RESOLUTE®, XIENCE V®, and CYPHER®.
Ordering Information
The document provides product ordering information, including stent diameters and lengths available for international use only. It emphasizes that the devices are restricted to sale by or on the order of a physician.
Contact Information
Elixir Medical Corporation's contact details are provided for both their headquarters in Sunnyvale, CA, and their office in Ireland.
Catalog excerpts
NOVOLIMUS ELUTING CORONARY STENT SYSTEM
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The Path to NEXT GENERATION DRUG ELUTING STENT TECHNOLOGY… 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. Engineered to maximize...
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Coating Technology 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 events 1 Improved polymer biocompatibility3 Low Drug Dose Sustainable performance with lower drug dose XIENCE V® 7.8 µm UNIQUE Drug Agent Proprietary Novolimus Drug Elution Established safety and performance • Clinically proven ‘olimus’ drug family • Active metabolite of Sirolimus Proprietary drug facilitates superior clinical efficacy1...
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CLINICAL Performance Sets New Standards EXCELLA II RCT (n = 210) L a t e L u m en L oss a t 9 M onths EXCELLA II Trial 82% 0 . 7 reduction in Late Loss 0.63 p<0.001 0.6 Comparative Trial results at 8–9 months5 CYPHER® (SIRIUS) RESOLUTE® XIENCE V® (RESOLUTE) (SPIRIT III) Significant reduction in late lumen loss, p = 0.001 Lowest published late lumen loss 4 Major Adverse Cardiac Events (MACE) at 3 Years Clinical Follow-up 14.0% 12.0% EXCELLA II Trial 61% 12.7% reduction in MACE Comparative Trial results at 3 years5 XIENCE V® RESOLUTE® (SPIRIT III) (RESOLUTE FIM) MACE defined as Target Lesion Revascularization,...
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CLINICAL Performance Sets New Standards EXCELLA II RCT (n = 210) Neointimal Volume Obstruction by IVUS at 9 Months EXCELLA II Trial 78% 25.0% reduction in % NI volume Comparative Trial results at 8–9 months 5 CYPHER® (SIRIUS) RESOLUTE® (RESOLUTE) Low neointimal volume obstruction Neointima-free Frame Ratio (% cross-sections without neointima coverage) EXCELLA III Trial 70.0% Comparative Trial results at 8–9 months 5 CYPHER® RESOLUTE® XIENCE V® (ENDEAVOR (RESOLUTE) (SPIRIT III) III Control Arm) Optimal neointimal coverage with low neointimal volume obstruction 1 » Serruys, P et. al, EuroIntervention...
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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Elixir Medical Corporation specializes in developing products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. Elixir Medical Corporate Headquarters 870 Hermosa Drive Sunnyvale, CA 94085 408.636.2000 [email protected] Elixir Medical Ireland IDA Business and Technology Park Carrick-on-Shannon...
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