Indication:  The Orsiro® Mission Sirolimus-Eluting Coronary Stent System is a drug-eluting balloon-expandable stent pre-mounted on a fast-exchange PTCA catheter delivery system. It is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST-elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.

Technical Data Stent

Stent material Cobalt chromium, L-605

Passive coating proBIO™ amorphous silicon carbide

Active coating BIOlute™ bioabsorbable drug matrix consisting of

sirolimus and polymer poly-l-lactide (PLLA)

Nominal drug content 1.4 μg/mm²

 

Delivery system

Catheter type                                    Fast-exchange

Recommended guide catheter       5 F (min. I.D.Ж  ≥ 0.056“)

Guide wire diameter                         0.014” (0.36 mm)

Usable catheter length                    140 cm

Balloon material                               Semi crystalline polymer

Coating (distal shaft)                        Hydrophilic

Coating (proximal shaft)                  Hydrophobic

Marker bands                                   Two swaged platinum-iridium markers

Proximal shaft diameter                 2.0 F

Distal shaft diameter                       2.7 F: ø 2.25 – 3.0 mm; 2.9 F: ø 3.5 – 4.0 mm

Nominal pressure (NP)                    10 atm

Rated burst pressure (RBP)            16 atm 

ЖI.D. = Inner Diameter

Ordering Information

 

 

 

 

 

 

 

 

References: 1. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file; 2. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 3. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result; 4. BIOTRONIK data on file; 5. Per investigators’ interpretation of preclinical studies with Orsiro as mentioned in Cassese et al. J Thorac Dis 2018;10(2):688-692; 6. When compared to FDA approved Drug Eluting Stents. BIOTRONIK data on file; 7. Foin N et al. International journal of cardiology. 2014 Dec 20;177(3):800-8; 8. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 9. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 10. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/Technologist Symposium; June 17, 2016; New York, USA; 11. Secco G et al. Time-related changes in neointimal tissue coverage of a novel Sirolimus eluting stent: Serial observations with optical coherence tomography. Cardiovascular Revascularization Medicine 2016; 17(1): 38-43; 12. Buiten R et al. Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels - A prespecified analysis of the randomized BIO-RESORT trial. JAMA Cardiol. 2019. doi:10.1001/jamacardio.2019.1776: Clinical Trials. gov: NCT01674803; 13. BIOTRONIK data on file, as of January 2020; 14. Taglieri N et al. Target lesion failure with current drug-eluting stents: Evidence from a comprehensive network meta-analysis. JACC 2020 13(24):2868-78; 15. Compared to Xience in BIOFLOW-V, based on three consecutive years; 16. Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017. 390(10105):1843-1852; 17. Kandzari D, et al. BIOFLOW-V: A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions Science. Presentation at ESC 2017; 18. Kandzari D et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents. JACC. 2018. 72(25):3287-97; 19. Kandzari, D et al. Ultrathin bioresorbablepolymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents for coronary revascularization: 3-year outcomes from the randomized BIOFLOW V trial. JACC: Cardiovascular Interventions. 2020, doi: 10.1016/j. jcin.2020.02.019; 20. Kandzari D et al. D et al. Ultrathin bioresorbable-polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents for coronary revascularization: 3-year outcomes from the randomized BIOFLOW V trial. JACC: Cardiovascular Interventions. 2020. Supplementary material.

Orsiro, Orsiro Mission, proBIO and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies. Synergy, Promus and Taxus are trademarks or registered trademarks of the Boston Scientific Group of Companies. Resolute, Integrity, Resolute Onyx and Resolute Integrity are trademarks or registered trademarks of the Medtronic Group of Companies. Xience and Xience Sierra are trademarks or registered trademarks of the Abbott Group of Companies. Biofreedom and BioMatrix are trademarks or registered trademarks of the Biosensors International Group. Cre8 is a trademark or registered trademark of the Alvimedica Group of Companies. Nobori is a trademark or registered trademark of the Terumo Group of Companies. Cypher is a trademark or registered trademark of the Cardinal Health Group of Companies.