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Orsiro® DES

Ultrathin struts§. Outstanding patient outcomes◊.
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Outstanding patient outcomes

Improving Patient Outcomes, Year After Year*

BIOFLOW-V (n = 1,334) FDA pivotal trial

Significant differences in TLF observed at year 1 and 2 were maintained and further increased at year 3 (8.6% vs. 14.4%, p = 0.003), driven by significant differences in TV-MI (5.5% vs. 10.1%, p = 0.004) and Ischemia-driven TLR (3.4% vs. 6.9%, p = 0.008) that favor Orsiro over Xience.1,2,3

TLF and components at 12, 24 and 36 Months

40%

lower TLF rate3 ф
(p=0.003)

46%

lower TV-MI rate3 ф
(p=0.004)

52%

lower Ischemia-driven TLR rate3 ф
(p=0.008)

TLF – Target Lesion Failure; TV-MI – Target Vessel Myocardial Infarction; TLR – Target Lesion Revascularization.
   
§As characterized with respect to strut thickness in Bangalore et al. Meta-analysis.
◊Based on investigator’s interpretation of BIOFLOW-V primary endpoint results.
*Compared to Xience, based on three consecutive years.
¤p-values for 36-m frequentist analysis.
ф vs. Xience, based on 36-m frequentist analysis.

Long-term performance

In the randomized, all-comers BIOSCIENCE trial (n= 2,119)4

Orsiro shows numerically equal or lower Stent Thrombosis (ST) in complex patients in comparison to Xience.

Ultrathin Struts – thinnest available in the US5

Thinner struts, faster endothelialization6

Improved outcomes start in the early phase

‡ Driven by peri-procedural MI events (<48 hours). In-hospital rate may include events > 48 hours. Δ Images: Secco G et al. Time-related changes in neointimal tissue coverage following a new generation SES implantation: an OCT observational study. Presented at: euro PCR, May 20, 2014; Paris, France.

Small Vessels. Ultrathin Struts. Big Difference.

Small vessel subgroup analysis (n = 1,506) of a large scale all-comers BIO-RESORT (n = 3,514) trial.

Fewer repeat target lesion revascularizations (TLR) compared to Resolute Integrity at 36 months.8

BIO-RESORT8

Small vessel sub-group

60%

Lower TLR rate vs. Resolute Integrity
(p = 0.009)

BIOFLOW-V3

52%

Lower TLR rate vs. Xience
(p = 0.008¤)
Ultrathin, ultra effective

Ultrathin vs. thin strut DES in a large scale meta-analysis including more than 11,000 patients9

16%

Relative risk reduction in TLF at 12 months (RR=0.84; 95% CI 0.72-0.99)

Excellent deliverability

Lower crossing profile

Improved acute performance – up to 7% lower crossing profile.10

Better push

Transmits up to 72% more force from hub to tip10

"Low profile and great deliverability coupled with superb clinical outcomes is a game-changer. In the current era of coronary stents, thinner struts are better and thinnest might be best."

Dr. Dean Kereiakes
BIOFLOW-V Site Principal Investigator

1. Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimuseluting
stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. October, 2017; 2. Kandzari D et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents: Journal of American College of Cardiology. 2018, doi: https//doi.org/10.1016/j.jacc.2018.09.019; 3. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j.jcin.2020.02.019; 4. Pilgrim T et al. 5-year outcomes of the BIOSCIENCE randomised trial. Supplementary appendix. Lancet, August, 2018; 5. When compared to FDA approved Drug Eluting Stents. BIOTRONIK data on file; 6. Foin N et al. Int J of Cardiol. 2014, 177(3); 7. 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 17.1 (2016): 38-43; 8. 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; Clinical Trials. gov: NCT01674803; 9. Bangalore S et al. Circulation. 2018, 138; 10. BIOTRONIK data on file; IIB(P)24/2018.

Synergy is a trademark or registered trademark of the Boston Scientific Group of Companies; Resolute, Integrity, Resolute Integrity and Resolute Onyx are trademarks or registered trademarks of the Medtronic Group of Companies; Xience, Xience Prime and Xience Xpedition are trademarks or registered trademarks of the Abbott Group of Companies. 

Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.  

Orsiro DES 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.