Orsiro

Vascular Intervention // Coronary
Drug-Eluting Stent System

Orsiro

 


 


Clinically proven

Extensive clinical program*



*status as of Feb 2017

 

 


Outstanding clinical results even in challenging subgroups
Orsiro has demonstrated consistently low target lesion failure (TLF) in all-comers trials compared to major modern drug-eluding stents (DES).



 

 

 


The new benchmark for DES

BIOFLOW-V 12-month clinical outcomes compared to Xience

 

 


In a post-hoc analysis of pooled patient-level data from three RCTs, Orsiro achieved a 96.9% probability of superiority* on TLF rate versus Xience.10


 

 

 


Highly deliverable
Designed for challenging cases, the Orsiro stent system provides better push and easier cross with a lower crossing profile.

 

 

 


Ultrathin 60 µm struts

Thinner struts make the difference

 

 

 


 

 

Orsiro

Indicated for discrete de novo stenotic lesions and in-stent restenotic lesions.*

 

 

Technical Data

Stent
Stent materialCobalt chromium, L-605
Passive coatingproBIO (Amorphous Silicon Carbide)
Active coatingBIOlute bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug
Drug dose1.4 μg/mm2
Strut thicknessø 2.25 - 3.0 mm: 60 μm (0.0024"); ø 3.50 - 4.0 mm: 80 μm (0.0031")
Delivery System
Catheter typeRapid exchange
Recommended guide catheter5F (min. I.D. 0.056")
Lesion entry profile0.017"
Guide wire diameter0.014"
Usable catheter length140 cm
Balloon materialSemi Crystalline Polymer material
Coating (distal shaft)Hydrophilic coating
Marker bandsTwo swaged platinum-iridium markers
Proximal shaft diameter2.0F
Distal shaft diameter2.6F: ø 2.25 - 3.5 mm; 2.8F: ø 4.0 mm
Nominal pressure (NP)8 atm
Rated burst pressure (RBP)16 atm

Compliance Chart

Balloon Diameter x Length (mm)
Nominal Pressureatm4888888
(NP)ø (mm)2.252.502.753.003.504.00
Rated Burst Pressureatm4161616161616
(RBP)ø (mm)2.502.773.053.333.884.44

Ordering Information

2.25364469364475364481364487364499364505364511391234391238
2.50364470364476364482364488364500364506364512391235391239
2.75364471364477364483364489364501364507364513391236391240
3.00364472364478364484364490364502364508364514391237391241
3.50364473364479364485364491364503364509364515391018391020
4.00364474364480364486364492364504364510364516391019391021

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VASCULAR INTERVENTION

Coronary Drug-Eluting Stent


1 von Birgelen et al. Very thin strut biodegradable polymer everolimus-eluting stents versus durable polymer zotarolimus-eluting stents in all-comers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial. The Lancet 2016. 10.1016.S0140-6736(16)31920-1 and presentation at TCT 2016;

2 TLF as a composite of cardiac death, target vessel-related myocardial infarction, or clinically indicated target lesion revascularization;

3 Pilgrim et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularization (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. The Lancet 2014.10.1016/S0140-6736(14)61038-2;

4 TLF as a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization;

5 Jensen et al. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization of Randomized Trials with Clinical Outcome VII trial. 10.1016/j.ahj.2015.05.009;

6 Target Lesion Failure as a composite of cardiac death, myocardial infarction (not related to other than index lesion), or taret lesion revascularization;

7 Piccolo R. Biodegradable polymer Sirolimus-eluting stents vs. Durable polymer Everolimus- eluting stents in patients with STEMI: Two-year follow-up of the BIOSCIENCE oral presentation, EuroPCR 2016;

8 Definite or probable stent thrombosis per ARC definition;

9 Preliminary analysis based on non locked data – Ton Slagboom, poster presentation, presented at TCT, November 2016;

10 Kandzari et al. Ultrathin Bioresobable Polymer Sirolimus-Eluting Stents versus thin durable Polymer Everolimus-eluting stents in patients Undergoing Coronary Revascularization (BIOFLOW-V): a randomized trial, The Lancet 2017;

11 Adapted from SCAAR data (August 24th, 2016) http://www.ucr.uu.se/swedeheart/99-scaar/forskning-scaar;

12 Compared to other DES included in SCAAR at five years;

13 Compared to Resolute Onyx;

14 The stent system is advanced through a model, to a point of blockage (simulating a total occlusion). The force at the proximal hub and the blockage is measured. Pushability is the force transmitted along the length of the catheter. IIB(P)31/2015 – IIB(P)85/2014-2;

15 Compared to Xience Xpedition;

16 The stent system is advanced through a stenosis model. Crossability is the mean resistance (mean force) registered by the stenosis during the complete passage of the stent delivery system. IIB(P)31/2015 – IIB(P)85/2014-2;

17 Stefanini GG, Taniwaki M, Windecker S. Coronary stents: novel development, Heart doi:10.1136/heartjnl-2012-303522;

18 Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol.2014 Dec 20;177(3):800-8;

19 Compared to Xience Expedition;

20 Expanded 3.0 mm diameter stents are radially compressed (15% of Ø) along full length. The force required to compress the stent is radial strength. BIOTRONIK data on file.

Synergy and Promus are registered trademarks of Boston Scientific; Resolute, Integrity, Resolute Integrity and Resolute Onyx are registered trademarks of Medtronic/Xience; Xience Prime and Xience Xpedition are registered trademarks of Abbott Cardiovascular Systems; Nobori and Ultimaster are registered trademarks of Terumo; BioMatrix is a registered trademark of Biosensors.

*Indication as per IFU.