Vascular Intervention Drug Eluting Stents Orsiro Orsiro Hybrid Drug Eluting Stent Industry's first hybrid DES
Orsiro An ideal combination of passive and active components The Orsiro Hybrid Drug Eluting Stent brings the optimal combination of effortless deliverability, coupled with a hybrid coating for treating coronary artery stenosis. This unique concept opens a new generation of drug eluting stents for improving patient outcomes.
hybrid drug eluting stent Industry's first hybrid stent design with passive and active components PROBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue BIOlute active coating contains a highly biocompatible polymer which delivers a Limus drug via a biodegradable matrix PRO-Kinetic Energy Stent System brings exceptional deliverability for reaching complex lesions unique innovation
Hybrid design Controlled drug release Immediately following implantation the drug elution from BIOlute starts. In vivo studies show that Orsiro elutes drug over 12-14 weeks. Biocompatible degradation The gentle degradation of the BIOlute polymer matrix into CO 2 and H 2 O causes minimal tissue burden and avoids inflammation. Invisible backbone When the BIOlute coating is gone only a PROBIO sealed stent is left in the arterial wall.
passive protection Sealed with a semi conductive barrier Once the stent is introduced into the body, water can immediately interact with the metal surface. PROBIO coating is a silicon carbide, semi conductive sealant, that greatly reduces the interaction between tissue or blood with the metallic surface of the stent. In vivo studies have shown up to a 96 % reduction of allergenic metal ions when the stent surface is coated with silicon carbide. 1 25 000 Concentration in ng/l 20 000 15 000 10 000 5 000 Competitor A cobalt nickel alloy Competitior B cobalt chromium alloy 0 Cobalt Nickel Tungsten Chromium PRO-Kinetic Energy with PROBIO coating 1 Data on file at BIOTRONIK. Quick facts BIOlute is based on a high molecular weight Poly-L-Lactic Acid (PLLA) a material that degrades by hydrolysis. The degradation process leads to reduction of polymer chain lengths and ends up in the production of CO 2 and water following the Krebs cycle. There is a long history of using PLLA in medical applications.
active effectiveness Biocompatible degradation One component of the BIOlute coating is a Poly-L-Lactic Acid (PLLA), as the base polymer material. This highly biocompatible material gentle degrades over time, keeping inflammatory response below a critical level throughout the process. Histopathological preclinical results, inflammation score 2 3.0 Inflammation Score 2.0 1.0 0.0 0.3 0.33 0.12 0.31 0.49 0.16 PRO-Kinetic Energy with PROBIO coating PRO-Kinetic Energy with PROBIO and PLLA coating 0.51 0.50 0.17 Orsiro with PROBIO and BIOlute coating 28 days 90 days 180 days 2 Overstretched minipig coronary artery model. Number of vessels 88. Data on file at BIOTRONIK. Optimal release kinetics In vivo pharmacokinetic, residual drug on stent after explantation From all drugs, sirolimus is the 100 Orsiro (n=10) most proven therapeutic and 90 80 BIOTRONIK has chosen this drug to be one component of BIOlute. The elution kinetic of Orsiro was Percent drug released 70 60 50 40 30 20 designed to maximize luminal 10 diameter. In vivo studies show that drug is eluted over 12-14 weeks. 0 0 20 40 60 80 100 Time (days)
arrive with ease New DES specific crimping An advanced crimping technique ensures a low crossing profile and secure stent retention without affecting the BIOlute coating. Advanced stent delivery system Expect effortless deliverability from the Orsiro delivery system, based on our Pantera PTCA balloon technology for optimal drug eluting stent deployment. Rugged and biocompatible matrix surface The BIOlute polymer is a thin circumferential coating. It keeps the stent profile low and does not stick to the underlying balloon material. During expansion, the BIOlute coating stays intact (mural coating thickness 7.5 µm), 200x magnification.
advanced stent design The Orsiro Hybrid DES uses our PRO-Kinetic Energy platform that offers exceptional bending flexibility without compromising scaffolding or fatigue resistance. This advanced stent design allows for expansion of the stent without affecting the BIOlute coating. Powerful cobalt chromium alloy Our advanced alloy material allow engineers to push the limits of design with novel concepts for thinner struts and lower crossing profile without compromising other aspects of the stent. Ultra thin strut design (60 µm) Struts of only 60 micron (0.0024") 3 result in exceptional flexibly and ensure minimal vessel wall injury, leading to better patient outcomes. 3 3.0 mm stent.
Technical data Stent Balloon diameter (mm) 2.25 2.5 2.75 3.0 3.5 4.0 Stent material Cobalt chromium, L-605 Passive coating PROBIO amorphous silicon carbide coating Active coating BIOlute biodegradable Poly-L-Lactic Acid (PLLA) eluting sirolimus Drug dose 1.4 µg/mm 2 Strut thickness 4 60 µm (0.0024") 80 µm (0.0031") Foreshortening 5 0 % -0.7 % Recoil 5 4.7 % 4.6 % Stent/artery ratio 18 % 16 % 14 % 13 % 12 % 11 % 4 Without active coating 5 Based on reference sizes 3.0/13, 4.0/15 Delivery system Catheter type Rapid exchange Shaft/balloon material Semi Crystalline Polymer material Coating (distal shaft) Hydrophilic coating Marker bands Two swaged platinum-iridium markers Guide wire diameter 0.014" Recommended guide catheter 5F (min. I.D. 0.056") Lesion entry profile 0.017" Usable catheter length 140 cm Proximal shaft diameter 2.0F Distal shaft diameter 2.6F: 2.25 3.5 mm 2.8F: 4.0 mm Nominal pressure (NP) 8 atm Rated burst pressure (RBP) 16 atm Specifications Laser rounded tip EFT (Enhanced Force Transmission) shaft Bioabsorbable BIOlute polymer eluting sirolimus PROBIO coating Shaft markers
new generation Compliance chart Inflation pressure (atm) Stent inner diameter (mm) 2.25 2.5 2.75 3.0 3.5 4.0 6 2.19 2.43 2.68 2.92 3.40 3.89 7 2.22 2.47 2.71 2.96 3.45 3.95 NP 8 2.25 2.50 2.75 3.00 3.50 4.00 9 2.28 2.53 2.79 3.04 3.55 4.05 10 2.31 2.57 2.82 3.08 3.60 4.11 11 2.34 2.60 2.86 3.12 3.64 4.16 12 2.37 2.64 2.90 3.16 3.69 4.22 13 2.40 2.67 2.94 3.20 3.74 4.27 14 2.43 2.70 2.97 3.25 3.79 4.33 15 2.46 2.74 3.01 3.29 3.83 4.38 RBP 16 2.50 2.77 3.05 3.33 3.88 4.44 17 2.53 2.81 3.09 3.37 3.93 4.49 18 2.56 2.84 3.12 3.41 3.98 4.55 19 2.59 2.87 3.16 3.45 4.02 4.60 NP: Nominal Pressure RBP: Rated Burst Pressure
Product ordering information Stent diameter (mm) Stent length (mm) 9 13 15 18 22 26 30 2.25 364469 364475 364481 364487 364499 364505 364511 2.5 364470 364476 364482 364488 364500 364506 364512 2.75 364471 364477 364483 364489 364501 364507 364513 3.0 364472 364478 364484 364490 364502 364508 364514 3.5 364473 364479 364485 364491 364503 364509 364515 4.0 364474 364480 364486 364492 364504 364510 364516
Orsiro Hybrid Drug Eluting Stent Industry's first hybrid DES 380085/B/109 BIOTRONIK AG All rights reserved. Specifications are subject to modification, revision and improvement. BIOTRONIK AG Ackerstrasse 6 8180 Bülach Switzerland Tel +41 (0) 44 8645111 Fax +41 (0) 44 8645005 info.vi@biotronik.com www.biotronik.com