Sirolimus Eluting Coronary Stent System 5-Years Randomized Clinical Follow-Up Translumina trust is what counts trust is what counts
DES with excellent long-term clinical outcome The Translumina PC drug-eluting stent, coated with Rapamycin (Sirolimus) and the biodegradable component polylactide (PLA), has an excellent history of pre-clinical and clinical results.[1,] In two independent trials ISAR-TEST and ISAR-TEST the PC showed angiographic and clinical equivalence with the Cypher stent after 1 year and years of follow-up.[,] Latest clinical data, published by G.Stefanini et al [5], show the excellent longterm outcome of the PC in a meta-analysis, comparing the clinical outcome after years in more than patients with the Cypher stent. This analysis shows for the first time that the definite Very Late Stent Thrombosis (VLST) can be reduced statistically significant by using the biodegradable PLA polymer coating technology of the PC. An additional sub-group analysis shows also benefit in difficult patient groups like diabetics and patients with acute myocardial infarkt. [,7] Due to this excellent clinical outcome the PC is recommended by the latest ESC guidelines for myocardial revascularization.[8] A PL YUKON Choice PC Micropores ctide Polyla Siro lim us Figure 1: Optical and Electron Microscope Pictures of the Yukon Choice PC. The unique microporous stent surface is coated abluminal with Sirolimus and PLA. The PLA ensures a better binding of the Sirolimus to the microporous stent surface and controls the release of the drug. The PLA is fully degradable according to the Krebs cycle. Figure : OCT follow-up years after implantation of a PC.
Published Pre-clinical and BMS Data [1,] The microporous surface shows a trend towards a reduced rate of binary restenosis with equivalent safety, which proves that it is safe and feasible to use as a drug reservoir for a DES. Extensive pre-clinical evaluations prove the safety of PC over BMS and conventional DES: Sirolimus [ng/mg tissue] Sirolimus release [%] 1 8 5 1 15 5 vascular tissue perivascular tissue * B A 1 1 Days Days Days PC shows a release of sirolimus up to weeks with a significant tissue concentration in the arterial segments. Comparison of smooth (electro-polished) stent surface (A) and rough (microstructured) stent surface (B). Magnification, 5x. Efficacy [, ] The ISAR-TEST is the first prospective randomized trial which compares different DES i.e. PC, Xience and Cypher for their efficacy & safety in over patients. HR,95HR [95%,95 CI [95%.8-1.1], CI.8-1.1], P=,59 P=,59 1 1 Xience Xience,9%,9% PC,1% PC,1% after MonthMonth after Month after 5 1 Target lesion revascularization (%) Target lesion revascularization (%) TLR Rate TLR Rate 5 Primary composite end point (%) Primary composite end point (%) MACEMACE Rate Rate 5 5 HR,97HR [95% CI [95%.78-1.], P=,79 P=,79,97 CI.78-1.], Xience Xience 1,% 1,% PC 1,9% PC 1,9% 1 Month after Month after Month after The PC with biodegradable polymer proves equivalence to Xience and Cypher in terms of late loss, binary restenosis, TLR and primary composite MACE despite having minimal polymeric load. Literature 1 YUKON Animal study: K.Steigerwald et al, Biomaterials, 9;, -7. Microporous Stent BMS study: Dibra et al, Cath. Cardiovasc.Interv., 5; 5, 7-8. ISAR-TEST trial, 1 year data (comparison with Cypher): R.Byrne et al, European Heart Journal, 9 ;, 1-9. ISAR-TEST trial, year data (comparison with Cypher): R.Byrne et al, JACC, 11 ; 58, 15-11. 5 Meta-Analysis ISAR-TEST +, LEADERS, years follow-up: G.Stefanini, European Heart Journal, ;, 1-. Subgroup-Analysis Diabetics: A. de Waha et al, International Journal of Cardiology 1, 18, 51-. 7 Subgroup-Analysis STEMI: A. de Waha et al, Eurointervention 1, published online. 8 S.Windecker et al, European Heart Journal (1) 5, 51 19. 9 S.Kufner et al, EuroIntervention 1;11:17-179.
Long Term Safety [ 5 ] One of the largest meta-analysis involving more than patients, which compared biodegradable polymer based DES with permanent polymer based DES demonstrated the long term excellent safety profile of the PC up to years. Definite stent thrombosis Definite stent thrombosis 5 5 Cumulative incidence (%) 1 HR.5 (95% CI.5,.9) p=.15 First Generation DES 1 Years after Years after PC Cumulative incidence (%) 1 HR.8 (95% CI.7,1,8) p=. HR. (95% CI.8,.1) p=. First Generation DES PC 1 Years after Years after Bernd Beck CEO Translumina GmbH At years follow-up, the PC shows a reduction of risk by 5% in definite Stent Thrombosis and by 78% in Very Late Stent Thrombosis (VLST) compared to First Generation DES without compromising on efficacy. Additionally, the PC achieved highest recommendations in the latest ESC Guidelines for myocardial revascularization (1) due to the excellent clinical outcome. [8] Excellent 5 year long-term clinical data [ 9 ] The final 5 year long-term clinical follow-up of the ISAR- TEST randomized controlled clinical trial showed excellent safety and efficacy data for the PC when compared with the Cypher and Xience V stent. The definite and probable stent thrombosis was only 1,% for the Yukon compared to 1,% and,% for the permanent polymer coated competitor DES. ARC definite or probable stent thrombosis Dear Reader, Since its foundation in the year translumina has been striving for unique product solutions to enhance patient outcome in the field of interventional cardiology. PC is our DES product that combines potent long-term clinical data with unique product performance. We are strongly committed to reliably support our customers with the most effective product solutions. Our production facility in Hechingen, Germany is designed to realize the highest standards for medical device manufacture and thus endorses our commitment of Made in Germany. From development to production and marketing, everything happens in our premises in Germany, thus guaranteeing optimal product reliability and best customer service. With us, trust is what counts. Biodegradable Polymer technology enhances the long-term safety when compared to permanent polymer DES. Yours, Bernd Beck Yukon Choice PC
Sirolimus Eluting Coronary Stent System The new stent delivery system The new designed luer The transparent luer has a positive, tactile feel assisting in navigation of the system. It is designed with an integrated protection to minimize any kinking. The new distal shaft High performance shaft provides excellent pushability and kink resistance. This feature allows for high manoeuvrability. The new flexible tip The soft tip material combined with an improved robust segment ensures perfect crossability and trackability. This feature allows easy access to all lesions. Stent features Unique stent surface The micro-porous stent surface, called PEARL Surface, favours better endothelialisation, which is essential for avoiding thrombosis and restenosis. SEM of the microporous stent surface Stent design Low stent profile homogeneous expansion increased radial force good side branch access flexible and deliverable strut thickness of 87µm in the range of CoCr platforms Technical specifications of the stent Medical Stainless Steel, 1 LVM, Surface containing micro-pores 1.1 mm Crossing profile Strut thickness Metallic surface area Balloon marker material Entry profile Proximal shaft diameter Distal shaft diameter Recommended guide wire Guiding Catheter,5 /,89 mm (Ø,5 mm), / 87 µm (Ø,5 mm) 1 - % Platinum / Iridium,1 /,1 mm 1,9 F,7 F,1 min. 5 F
Sirolimus Eluting Coronary Stent System Product matrix / Ordering information Small vessel design (SV) Balloon Stent length [mm] & Article number Ø [mm] 8 1 1 8 Ø, YCPC8 YCPC YCPC1 YCPC YCPC1 YCPC YCPC8 YCPC Ø,5 YCPC58 YCPC5 YCPC51 YCPC5 YCPC51 YCPC5 YCPC58 YCPC5 Medium vessel design (MV) Balloon Stent length [mm] & Article number Ø [mm] 8 1 1 8 Ø,75 YCPC78 YCPC7 YCPC71 YCPC7 YCPC71 YCPC7 YCPC78 YCPC7 YCPC7 Ø, YCPC8 YCPC YCPC1 YCPC YCPC1 YCPC YCPC8 YCPC YCPC Ø,5 YCPC58 YCPC5 YCPC51 YCPC5 YCPC51 YCPC5 YCPC58 YCPC5 YCPC5 Ø, YCPC8 YCPC YCPC1 YCPC YCPC1 YCPC YCPC8 YCPC YCPC Compliance chart Inflation pressure [bar or 1 5 Pascal] NP Balloon RBP Ø [mm] 7 8 9 1 11 1 1 15 1 17 19* * Ø, 1,9 1,9 1,97,,,7,1,1,17,,,7,5,8,1 Ø,5,,,7,5,5,57,,,7,71,7,77,81,8,88 Ø,75,5,8,7,75,78,8,85,88,9,95,98,1,8,1, Ø,,89,9,97,,,8,,15,19,,,,,7,1 Ø,5,7,,,5,5,58,,7,71,75,79,8,88,9,9 Ø,,85,9,95,,5,1,1,1,,1,,1,,51,5 * calculated Art.Nr. MK59/REV 17 Translumina GmbH All Rights Reserved Yukon,, Pearl Surface and Translumina are registered trademarks of translumina GmbH Please refer to the Instruction for Use supplied with these devices for indications, contraindications, adverse effects, suggested procedures, warnings and precautions. Translumina GmbH Neue Rottenburger Strasse 5 779 Hechingen Germany info@translumina.de t + 9 771 98 9 - f + 9 771 98 9 - www.translumina.de now available in more than countries.