Clinical Studies | Orsiro
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Hervorragende Patientenergebnisse

Orsiro wurde 2011 ins Leben gerufen und verfügt über ein umfangreiches klinisches Programm mit mehr als 48.500 eingeschlossenen Patienten. Orsiro Mission verwendet das klinisch erprobte Orsiro DES für ein völlig neues Liefersystem.

BIOFLOW-V

BIOFLOW-V (n = 1,334) the FDA pivotal trial.3,4,5,6,7
Improving patient outcomes, year after year*

BIOFLOW-V: 3-year results from the FDA pivotal trial

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BIOFLOW-V: 3-year results from the FDA pivotal trial

40%

lower TLF rate6 ф

[p=0.003]

46%

lower TV - MI rate6 ф

[p=0.004]

52%

lower Iscemia-driven TLR rate6 ф

[p=0.008]

TLF – Target Lesion Failure; TV-MI – Target Vessel Myocardial Infarction; TLR – Target Lesion Revascularization.
*Compared to Xience, based on three consecutive years. ¤p-values for 36-m frequentist analysis. ф vs. Xience, based on 36-m frequentist analysis.

BIOSTEMI

Continued Superiority of Orsiro over Xience in STEMI patients at 2 years*

CO-PRINCIPAL INVESTIGATOR OF THE BIOSTEMI RCT DISCUSSES KEY FINDINGS AT 2-YEAR FOLLOW UP

Juan F. Iglesias, MD, Geneva, Switzerland

“The Orsiro stent should now be considered as the benchmark stent for stent comparison mainly in patients with ACS and STEMI”
Juan F. Iglesias, MD, Geneva, Switzerland

*based on TLF rates ∆ Posterior probability of superiority in STEMI in comparison to Xience at 24 months with respect to TLF, based on combined data set of BIOSTEMI and BIOSCIENCE STEMI groups. ACS – Acute Coronary Syndrome, STEMI – ST-El

CO-PRINCIPAL INVESTIGATOR OF THE BIOSTEMI RCT DISCUSSES KEY FINDINGS AT 2-YEAR FOLLOW UP

Juan F. Iglesias, MD, Geneva, Switzerland

BIO-RESORT

Small Vessels. Ultrathin Struts. Big Difference9

BIO-RESORT: Small Vessels. Ultrathin Struts. Big Difference.

BIO-RESORT: Small Vessels. Ultrathin Struts. Big Difference.

1. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file; 2. BIOTRONIK data on file, status January 2020; 3. 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 Oct 21; 390(10105):1843-1852; 4. 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; 5. Kandzari D et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents. Journal of the American College of Cardiology. 2018 Dec 17;72(25):3287-97; 6. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j. jcin.2020.02.019; 7. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020 Supplemental Material; 8. Iglesias JF et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial; Lancet, September, 2019; 9. 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. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1776; ClinicalTrials.gov: NCT01674803. 

 

Resolute, Resolute Onyx and 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.

Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

Disclaimer
Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

Orsiro Mission is currently not available in the US.


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Specifications are subject to modification, revision and improvement.