1. Progenitor Endothelial Cell Capturing with a Drug Eluting Stent
Stephen M Rowland, PhD VP R&D and Clinical Affairs, OrbusNeich Medical
Washington, DC
25 February, 2013

2. Disclosure
Employee of OrbusNeich Medical, Inc.

4. COMBO Dual Therapy Stent
316L Stainless Steel Stent Strut Cross-section
Nanometer Thick
CD34 Antibody
Layer
Abluminal
Sirolimus
Release Matrix
3 – 5 μm
316L SST
Stent Strut
100 μm
Lumen SIDE
Design features:
Abluminal biodegradable polymer matrix
Sirolimus elution
Genous technology for accelerated endothelial coverage
Vessel SIDE

5. Clinical Performance
Conducted 3 studies with the Combo stent including multiple imaging modalities:
REMEDEE stable angina patients (N=180)
EGO Combo stable angina patients (N=61)
REMEDEE OCT STEMI & non-STEMI patients (N=60)
Shed light on 3 aspects of healing:
EARLY: Strut “coverage”
months
MID TERM: restenosis
NI formation & Late Loss
9 months
LONG TERM: Biostability
NI 9 months
OCT: Low Intensity Tissue & Micro Vessels in NI
IVUS-VH: Necrotic Core in NI

6. Strut Coverage % (OCT) Median & IQR
REMEDEE OCT, U. Landmesser, TCT 2012, Miami, FL
EGO Combo; S. Lee, TCT 2012, Miami, FL
* BASE-OCT: Pasi Karjalainen, ICI meeting 2010

7. Cumulative Frequency Distribution of In-stent Late Lumen Loss*
Haude M et al., TCT 2012, Miami, FL

8. Histograms of In-stent Late Loss (QCA)
Combo (REMEDEE, 9 mo)
n=109
Taxus (REMEDEE, 9 mo)
n=52 %
In-Stent Late Loss [mm]
In-Stent Late Loss [mm]
Genous * (Healing IIb, 6 mo)
n=86
ISLL distributions show different patterns:
Combo slight tail
Taxus bi-modal appearance
Genous similar to BMS %
In-Stent Late Loss [mm]
Haude M et al., TCT 2012, Miami, FL

9. NI Tissue Characterization (IVUS-VH) REMEDEE (9 month FU)
p = 0.08
p = 0.28
p = 0.33
p = 1.00
p = 0.52
n = 10
n = 5
Haude M et al., Poster Presentation: 2012, EuroPCR, Paris, France

10. NI Tissue Characterization (OCT) REMEDEE (9 month FU)
p = 0.08
p = 0.40
p = 0.04
n = 24
n = 10
Haude M et al., Poster Presentation: 2012, EuroPCR, Paris, France

11. Lessons Learned Signature of the Combo Stent reflects:
Abluminal drug delivery and
Luminal EPC capture
Translating into:
Early
Rapid strut coverage with endothelium
Mid Term
DES-like late loss (control of restenosis)
Long Term
Uniform homogeneous tissue with a reduced accumulation of newly formed necrotic core/neo-atherosclerosis

12. COMBO Dual Therapy Stent Clinical Trial Program
REMEDEE
EGO COMBO
REMEDEE OCT
COMBO Post Market
COMBO
Japan & US
N= 183
N= 61
N= 60
N= TBD
N= TBD
Randomized Multicenter Trial with 9 Month Angiographic FU
Prospective, Single Center Serial OCT Assessment from 2-5 Months
“All Comers” Expanded Indication
Optimal DAPT Duration
Mechanisms of Healing Platform Development
HBD WG1 PoC
Single Protocol
Randomized
Randomized Multicenter OCT Assessment at 2 Months vs EES
OCT & IVUS / VH Subset Analyses
Completed
Clinical FU Ongoing
2-5 and 9 Months Completed
Pending 24 Month FU
Completed
Clinical FU Ongoing
Under Preparation
Under Preparation

13. Thank You