Orsiro

Vascular Intervention // Coronary
Drug-Eluting Stent System

Orsiro®
Ultrathin struts. Outstanding patient outcomes.

 

 


 


Orsiro

Ultrathin strut DES for outstanding patient outcomes


Outstanding patient outcomes

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

Orsiro shows statistically significant lower Target Lesion Failure (TLF) rates at 12 and 24 months in a more-comers population with >50% ACS in both study arms.1,2

 

 

 
 
 

 
 
 
 
"Results from this trial establish
a new standard for safety and
efficacy among contemporary
drug-eluting stents"


Dr. David Kandzari
BIOFLOW-V US Principal Investigator


TLR – Target Lesion Revascularization; TV-MI - Target Vessel Myocardial Infarction

 

 

 

 

 

 

 

Ultrathin Struts - thinnest available in the US3


Thinner struts, faster endothelialization4
 
Improved outcomes start in the acute phase

 


 
 

 





Excellent deliverability

 
 
"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

 

 

 

 

 

 

 

Orsiro®

Sirolimus-Eluting Coronary Stent System


Orsiro 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 5F (min. I.DΔ ≥ 0.056“)
Guide wire diameter 0.014” (0.36 mm)
Usable catheter length 140 cm
Balloon material Polymer
Coating (distal shaft) Hydrophilic coating
Marker bands Two platinum-iridium markers
Proximal shaft diameter 2.0F
Distal shaft diameter ø 2.25-3.5 mm: 2.7F
ø 4.0 mm: 3.0F
Nominal pressure (NP) Ø 2.25-2.75, 3.5-4.0 mm: 7 atm
Ø 3.0 mm: 8 atm
Rated burst pressure (RBP) 16 atm
  ΔI.D. = Inner Diameter

Compliance Chart

Balloon Diameter x Length (mm)
       ø 2.25
x 9-30 
ø 2.50
x 9-40
ø 2.75
x 9-40
ø 3.00
x 9-40
ø 3.50
x 9-40
ø 4.00
x 9-40
Nominal Pressure atm** 7 7 7 8 7 7
(NP) ø (mm) 2.26 2.52 2.75 3.07 3.54 4.00
Rated Burst Pressure atm** 16 16 16 16 16 16
(RBP) ø (mm) 2.57 2.92 3.14 3.42 3.95 4.48
Maximum diameter for post-dilation ø (mm) 3.5 3.5 3.5 3.5 4.5 4.5
                     **1 atm = 1.013 bar

Ordering Information

Stent ø (mm) Stent length (mm)
  9 13 15 18 22 26 30 35 40
2.25 401729 401735 401741 401747 401753 401759 401765 - -
2.50 401730 401736 401742 401748 401754 401760 401766 404667 404673
2.75 401731 401737 401743 401749 401755 401761 401767 404668 404674
3.00 401732 401738 401744 401750 401756 401762 401768 404669 404675
3.50 401733 401739 401745 401751 401757 401763 401769 404670 404676
4.00 401734 401740 401746 401752 401758 401764 401770 404671 404677

Contact

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Image
Orsiro Image

Vascular Intervention

Coronary Drug-Eluting Stent


1 Kandzari D et al. Journal of the American College of Cardiology. 2018 Sep 23:25565;

2 Kandzari D et al. The Lancet. 2017 Oct 21;390(10105):1843-52;

3 When compared to FDA approved Drug Eluting Stents. BIOTRONIK data on file;

4 Foin N et al. International journal of cardiology. 2014 Dec 20;177(3):800-8;

5 Secco G. Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):38-43;

6 Bangalore S et al. Circulation. 2018 Jun 26:CIRCULATIONAHA-118;

7 Kok M et al. EuroIntervention 2018; published online May 23. DOI: 10.4244. EIJ-D-18-00336;

8 BIOTRONIK data on file; IIB(P)24/2018.
*Synergy is a registered trademark 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.
Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.