Orsiro Hybrid Drug Eluting Stent Industry's first hybrid DES

Transcription

1 Vascular Intervention Drug Eluting Stents Orsiro Orsiro Hybrid Drug Eluting Stent Industry's first hybrid DES

2 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.

3 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

4 Hybrid design Controlled drug release Immediately following implantation the drug elution from BIOlute starts. In vivo studies show that Orsiro elutes drug over 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.

5 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 Concentration in ng/l 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.

6 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 Inflammation Score PRO-Kinetic Energy with PROBIO coating PRO-Kinetic Energy with PROBIO and PLLA coating 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 BIOTRONIK has chosen this drug to be one component of BIOlute. The elution kinetic of Orsiro was Percent drug released designed to maximize luminal 10 diameter. In vivo studies show that drug is eluted over weeks Time (days)

7 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.

8 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 mm stent.

9 Technical data Stent Balloon diameter (mm) 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 % 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 ") Lesion entry profile 0.017" Usable catheter length 140 cm Proximal shaft diameter 2.0F Distal shaft diameter 2.6F: 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

10 new generation Compliance chart Inflation pressure (atm) Stent inner diameter (mm) NP RBP NP: Nominal Pressure RBP: Rated Burst Pressure

11 Product ordering information Stent diameter (mm) Stent length (mm)

12 Orsiro Hybrid Drug Eluting Stent Industry's first hybrid DES /B/109 BIOTRONIK AG All rights reserved. Specifications are subject to modification, revision and improvement. BIOTRONIK AG Ackerstrasse Bülach Switzerland Tel +41 (0) Fax +41 (0) [email protected]