Ridaforolimus Eluting Coronary Stent System Advancing Deliverability for the Road Ahead
The Coronary Stent System Raising the Bar on Drug-Eluting Stent Technology Introducing the Coronary Stent System, the next generation in drug-eluting stent technology. No other stent combines a unique metallic spring tip with an innovative dual-pattern strut design that advances deliverability in highly complex anatomy for outstanding clinical outcomes. Exceptional Outcomes by Design Drive Safely with Certainty Whether faced with difficult lesions or calcifications, the DES lives up to the promise of outstanding efficacy and safety results. Exceptional Results in the BIONICS Pivotal Study In BIONICS, a global more-comers randomized study of 1,919 patients at 76 sites, the DES (n=958) demonstrated outstanding results including a 12 month Target Lesion Failure (TLF) of 5.4%, Target Lesion Revascularization (TLR) of 3.0%, and Late Stent Thrombosis of % while demonstrating non-inferiority to (n=961). % Stent Thrombosis % TLF 1 7.5 5.0 2.5 1.25 1.0 0.75 0.5 0.25 5.4% Target Lesion Failure at 12 Months 1 5.4% DES showcases exceptional clinical outcomes at 12 months in a broad, less-selective more comers population. % Late Stent Thrombosis at 12 Months 0.4% (p=013) For non-inferiority BIONICS Trial (p=0.37) 5.4% 0.8% Probable/Definite Stent Thrombosis 6.1% 2 6.7%3 % Other US Trials (p=0.25) (n=958) (n=961) 0.3% Late Stent Thrombosis 3.0% TLR at 12 Months The BIONICS pivotal study had fewer exclusions of challenging patients than most pivotal studies on other stents. Patients with recent (<24 hours) ST-segment elevation myocardial infarction, left ventricular ejection fraction <30%, active stent thrombosis, creatinine clearance <30 ml/min, and prior PCI 12 months, and those unlikely to adhere to dual antiplatelet therapy, were excluded. Even with this more comers study design, the DES demonstrated outstanding clinical outcomes. DES demonstrated low stent thrombosis rates with no events beyond 30 days. Pioneering Cardiovascular Intervention Cordis has partnered with Medinol to launch the stent an innovation designed to meet the unique demands of the ever-changing cardiovascular environment. Tapping more than 20 years of experience in the coronary stent space, these two innovative leaders are committed to raising the bar on the quality and performance of stenting systems to increase value to customers and the patients they serve. With more than two million stents delivered globally, and decades of research, development, and manufacturing experience, Medinol s cutting-edge cardiovascular intervention technology continues to demonstrate exceptional clinical results. Cumulative Percent 100 80 60 40 20 NIREUS: Low Late-Loss at 6 months 0-0.8-0.6-0.4-0.2 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 In Stent Late Loss (mm) In NIREUS, a European pivotal study, the DES demonstrated unprecedented results with an in-stent Late Loss of 4mm at 6 months (n=201). The DES was non-inferior to at 6 months for the primary angiographic endpoint. 4 mm (n=201) 3 mm (n=101)
No Stent Delivers More Navigate with Superior Deliverability and Crossability The DES was designed to help you navigate with ease, even in highly complex anatomies. The unique metallic spring tip, narrow width struts and reinforced hypotube offer excellent pushability, agility and flexibility. Excellent Tip Flexibility Highest Tip Pushability 800 700 600 4Times the TIP PUSHABILITY 4 of Onyx 500 Enhanced Crossability Spring tip enables force transfer designed for pushability, ease of placement, and kink resistance Force [gr] 400 300 Open Coils Flexibility and agility to navigate through and around challenges Improved Flexibility & Agility The closed spring tip is designed to navigate through complex anatomy including tortuosity, calcification and previously implanted stents 200 100 Onyx Xpedition Promus Premier Integrity Polymer Jacket Optimized for flexibility, pushability, and crossability Trackability & Tip Integrity Plastic tips used in most stents may incur flaring and gaping. Conversely, the stent s metallic spring tip closely hugs the wire on a curve, avoids flaring and gaping, and contributes to crossability. Extended length of shaft has hydrophilic coating which minimizes friction to improve deliverability Closed Coils Enhanced pushability to cross complex lesions Thermo-Treated Reinforced Hypotube Reinforced hypotube for improved hub-to-tip force transfer, designed to navigate through tortuous anatomy without kinking Metallic Material Will not buckle like plastic tips
Delivering a Balanced Strut Design Engineered for Conformability and Strength Lowest Metal Footprint Strut to vessel contact matters. The DES was designed to deliver the lowest Metal-to-Artery Ratio. No need to choose between strength or conformability. The DES leverages a next generation smart stent design to combine the best of both worlds. Innovative Dual-Pattern Strut Design Thin Struts 90 µm Designed for healing Thickness Ultra-Narrow and Narrow Width Struts Vessel wall footprint W strut 40µm 72µm 90µm 95µm 96µm Onyx Width Low Metal-to-Tissue Contact Ratio The DES boasts a unique scaffolding design and the narrowest strut width compared to, and Onyx. Ultra-Narrow Width Struts 40 µm Designed for conformability Narrow Width Struts 72 µm Provide excellent radial strength 18% 16% 14% 12% 10% 8% 6% Metal-to-Artery Ratio Lower is better Artery to Metal Contact Ratio Chart Metal-to-Artery Ratio (Metal Footprint): Percent of the vessel s wall that is covered by the stent s struts. The stent s surface area is divided by the area of the vessel s interior lumen. 4% 2% 0% Onyx Designed for Conformability State-of-the-Art Polymer Technology Uniform cell size Reduces the risk of tissue prolapse by maintaining a uniform scaffolding even on a curved vessel. When deployed on a curve other stents leave large gaps which could increase the risk for tissue prolapse and strut overlap 5. The DES is the first and only drug-eluting stent coated with an elastomeric polymer that resists the cracking seen with other durable polymers. The durable elastomer coating is designed for long-term integrity. Novel coating with elastic, non-cracking properties designed to reduce surface irregularities and deformations to provide a controlled drug elution. Optimal combination of coating process and design for predictable and uniform release of Ridaforolimus, a Rapamycin analogue. Onyx Actual images of stents on curved wire. DES polymers after soaking in plasma at body temperature for 45 days () and 50 days (,, ).
Ridaforolimus Eluting Coronary Stent System For product in-service or support, contact your Cordis Sales Representative. Ordering Information Stent Diameter (mm) Stent Length (mm) 8 12 15 17 20 24 28 33 38 44 2.50 LUN250R08C LUN250R12C LUN250R15C LUN250R17C LUN250R20C LUN250R24C LUN250R28C LUN250R33C 2.75 LUN275R08C LUN275R12C LUN275R15C LUN275R17C LUN275R20C LUN275R24C LUN275R28C LUN275R33C LUN275R38C LUN275R44C 3.00 LUN300R08C LUN300R12C LUN300R15C LUN300R17C LUN300R20C LUN300R24C LUN300R28C LUN300R33C LUN300R38C LUN300R44C 3.50 LUN350R08C LUN350R12C LUN350R15C LUN350R17C LUN350R20C LUN350R24C LUN350R28C LUN350R33C LUN350R38C LUN350R44C 4.00 LUN400R08C LUN400R12C LUN400R15C LUN400R17C LUN400R20C LUN400R24C LUN400R28C LUN400R33C LUN400R38C LUN400R44C References: 1. Ridaforolimus Eluting Coronary Stent System Instructions for Use 2. : ABSORB III. Ellis et al.; Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease; N Engl J Med 2015; 373:1905-1915. 3. : EVOLVE II. Kereiakes et al.; Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent; Circ Cardiovasc Interv 2015; 8:e0023372. 4. For healthcare professionals only. 2018 Cardinal Health. All Rights Reserved. CORDIS and Cordis LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners. is manufactured by Medinol and distributed by Cordis Corporation. Important information: Prior to use, refer to the instruction for use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions. 100510210 02/2018