Orsiro
MEDIKAMENT-FREISETZENDER STENT
Indiziert für diskrete de-novo-Läsionen und In-Stent Restenosen
Klicken Sie hier für mehr Informationen: www.orsiro.com
DIE WICHTIGSTEN MERKMALE
- Klinisch bewährt
- Gute Platzierbarkeit
- Ultradünne 60 μm1 Streben
Orsiro. Clinically proven. Highly deliverable.
Umfangreiches klinisches Programm
Umfangreiche klinische Daten, auch in herausfordernden Subgruppen.
> 32.500 eingeschlossene Patienten2
> 50.500 Patienten insgesamt geplant2
- Kleine Gefässe: 1.598 Patienten
- Diabetiker: 1.487 Patienten
- STEMI: 1.081 Patienten
Hervorragende klinische Ergebnisse
Orsiro hat in allen All-Comers-Studien konstant niedrige TLF-Raten im Vergleich zum führenden modernen DES gezeigt.
Langzeit-Sicherheit und -Wirksamkeit
Orsiro zeigt
- 2,2% Restenose3 (vs 3,1% Xience Xpedition15 und 3,0% Resolute Integrity15)4
- 0,7% Definitive Stentthrombose5 (vs 0,9% Xience Xpedition und 0,9% Resolute Integrity)
- 10,2% Versagen an der Zielläsion6 (TLF vs 11,3% Xience Prime15)7
Gemacht für herausfordernde Fälle
Besserer Vorschub:
Orsiro-Stentsystem überträgt bis zu 57 %8 mehr Kraft vom Hub auf die Spitze.9
Einfachere Passage:
Orsiro-Stentsystem erfordert bis zu 68 %10 weniger Kraft, um eine Läsion erfolgreich zu passieren11
Dünnere Streben machen den Unterschied
- Störungsfreierer Fluss12
- Verbessert Re-Endothelialisierung12
- Bewährte Radialkraft13,14
BIO-RESORT RCT
- All-comers, multi-center, assessor and patient-blinded, randomized, non-inferiority design
- Number of patients: 3514
- Primary endpoint: Target Vessel Failure (TVF) at 12 months as a composite of CD, target vessel-related MI or TVR
BIOSCIENCE RCT
- Prospective, all-comers, multi-center, randomized, non-inferiority design
- Number of patients: 2119
- Primary endpoint: Target Lesion Failure (TLF) at 12 months
BIOFLOW-I FIM Trial
- Prospective, multi-center, non-randomized, first-in-man trial
- Number of patients: 30
- Primary endpoint: In-stent Late Lumen Loss (LLL) at 9 months by QCA
BIOFLOW-II RCT
- Prospective, multi-center, randomized, controlled trial comparing the Orsiro to Xience Prime
- Number of patients: 452
- Primary endpoint: In-stent LLL at 9 months
BIOFLOW-III Registry
- International, prospective, multi-center open-label, registry of the Orsiro DES in daily clinical practice
- Number of patients: 1356
- Primary endpoint: TLF at 12 months
SORT OUT VII RCT
- All-comers, multi-center, randomized, non-inferiority design
- Number of patients: 2525
- Primary endpoint: TLF at 12 months
ORIENT
- Prospective, multi-center, randomized, controlled trial comparing Orsiro to Resolute Integrity
- Number of patients: 372
- Primary endpoint: In-stent LLL at 9 months
Technische Daten
| Stent | |
|---|---|
| Stentmaterial | Kobalt-Chrom, L-605 |
| Passive Beschichtung | proBIO (Amorphes Siliziumkarbid) |
| Aktive Beschichtung | BIOlute Bioresorbierbare BIOlute-Poly-L-Milchsäure (PLLA) mit Abgabe von Limus-Medikament |
| Wirkstoffdosis | 1,4 μg/mm2 |
| Strebendicke | ø 2,25 - 3,0 mm: 60 μm (0.0024"); ø 3,50 - 4,0 mm: 80 μm (0,0031") |
| Stentträgersystem | |
|---|---|
| Kathetertyp | Rapid-Exchange |
| Empfohlener Führungskatheter | 5F (min. ID: 0,056") |
| Läsionseintrittsprofil | 0.017" |
| Durchmesser des Führungsdrahtes | 0.014" |
| Arbeitslänge des Katheters | 140 cm |
| Ballonmaterial | Semikristallines Polymermaterial |
| Beschichtung (distaler Schaft) | Hydrophile Beschichtung |
| Markierungsbänder | Zwei eingestanzte Platin-Iridium-Marker |
| Proximaler Schaftdurchmesser | 2,0 F |
| Distaler Schaftdurchmesser | 2,6 F: ø 2,25 - 3,5 mm; 2,8 F: ø 4,0 mm |
| Nominaldruck (NP) | 8 atm |
| Berstdruck (RBP) | 16 atm |
Compliance-Tabelle
| Ballondurchmesser x Länge (mm) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nominaldruck | atm4 | 8 | 8 | 8 | 8 | 8 | 8 | ||||||||||||
| (NP) | ø (mm) | 2,25 | 2,50 | 2,75 | 3,00 | 3,50 | 4,00 | ||||||||||||
| Berstdruck | atm4 | 16 | 16 | 16 | 16 | 16 | 16 | ||||||||||||
| (RBP) | ø (mm) | 2,50 | 2,77 | 3,05 | 3,33 | 3,88 | 4,44 | ||||||||||||
Kontakt
1 ø 2,25 - 3,0 mm
2 Status as of February 2017
3 Restenosis includes stent thromboses and non-acute stent occlusions
4 In SCAAR Registry (n > 7000 patients); Adapted from SCAAR data (August 24th 2016) http://www.ucr.uu.se/swedeheart/99-scaar/forskning-scaar
5 per ARC definition
6 Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
7 In BIOFLOW-II trial (n = 452 patients); Preliminary analysis based on non-locked data – Ton Slagboom – Poster presentation. TCT, Washington DC, USA, November 2016
8 Compared to Resolute Onyx
9 The stent system is advanced through a model, to a point of blockage (simulating a total occlusion). The force at the proximal hub and at the blockage is measured. Pushability is the force transmitted along the length of the catheter. - IIB(P)31/2015 - IIB(P)85/2014-2
10 Compared to Xience Xpedition
11 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
12 Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014 Dec
13 177(3):800-8; 20 Compared to Synergy
14 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. - TR135971 Rev C
15 Synergy is a registered trademark of Boston Scientific / Resolute, Integrity and Resolute Integrity are registered trademarks of Medtronic / Xience Prime/Xpedition is a registered trademark of Abbott Cardiovascular Systems