ACSAssured COMBO Safety forAcute Coronary SyndromeSafety and Durability. Reliability in Short DAPT Flexibility.

1 REMEDEE Registry 2 REDUCE ACS Trial

Consistent clinical validation for tru

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Minimum Requirement

COMBO Dual Therapy StentDAPTFlexibility

StablePatients1

1mACS

Patients2

3m

The First DES with 3 month DAPT flexibility in ACS

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ORDERING INFORMATION

Bioabsorbable Polymer

Confident Deliverability

Hub

Proximal Shaft (2.1F)

Radiopaque Markers Rx Port

Distal Shaft (Ø 2.5 - 3.0 mm: 2.6F Ø 3.5 - 4.0 mm: 2.9F)

Catheter Working Length (138 cm)

(0.014”)

Transition Zone

Exit Markers

TECHNICAL SPECIFICATIONS

1 2.5 mm stent. (data on file)

CORONARY STENT

Drug (dose)

Polymer

Sirolimus (5.0 µg/mm)

Abluminal bioabsorbable polymer

Biological coating Anti-CD34 antibody

Maximumstent cellopening

4.5 mm

EMEA HEADQUARTERSDrs. W. van Royenstraat 5 3871 AN HoevelakenThe NetherlandsPhone +31.33.254.1150 Toll Free Phone 00800.0254.1150*

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OrbusNeich and COMBO are Trademarks of OrbusNeich Medical, Inc. All data and photos on file. Illustrations are not to be considered as engineering drawings or photos.

Pharmaceutical agent reduces neointimal hyperplasia

Anti-CD34 antibody acceleratesendothelial headling

Bioabsorbable polymer transports and releases drug from an abluminal coating

Robust stent design with improved deliverability to easily treat all “workhorse” cases

Healing is a biological process that occurs as a consequence to injury.For complete healing, two steps are required:

Drug

TRADITIONAL

Polymer

StentPlatform

1 Atherosclerotic rabbit model at 28 days shows complete endothelial coverage with scanning electron microscopy. F. Otsuka,Poster presentation at TCT 20132 Atherosclerotic rabbit model at 28 days shows functional endothelial junctions with CD31/PECAM-1 staining. F. Otsuka, Poster presentation at TCT 2013 S. Lee et al. The EGO-Combo study. Circ. Cardiovasc Interv. 2016;9e0034609

Strut Level Neointimal Thickness (mm)p < 0.001 p < 0.003

Strut Level Neointimal Volume (mm3)

-14.3%

0.14 29.9

0.1226.2

9-Month 24-Month 9-Month 24-Month

-12.5%

COMBO: 92% p<0.001 Xience: 75%

S. Saito et al., European Heart J (2018)39:2460-2469

Safety and Durability COMBO Plus is the first DES that controls neointimal proliferation and promotes accelerated healing via rapid EPC capture

Unique Neointimal Regression between 9 and 24 months

Significantly greater and healthier tissue coverage at 1 year on 140 subjects under OCT analysis

Consistent Safety and Efficacy in ACSand Stable patients

1 REDUCE ACS, REMEDEE ACS Registry, NUHS COMBO AMI Registry2 REMEDEE FIM, HARMONEE, REDUCE, RECOVERY, SORT OUT X3 EGO COMBO 24m follow up, HARMONEE 1-year follow up4 REMEDEE FIM Study, Catheter Cardiovasc Interv. 2019;1–95 On-label recommendation based on REDUCE, REMEDEE and MASCOT registries

ACS focused data on 2,200+ patients with low cardiac death and ST events1

Randomized data on 5,800+ patients2

Late luminal gain and superior healthy tissue coverage under OCT3

0% stent thrombosis at 5 year follow up4

Short DAPT flexibility in both ACS and stable patients5

Active Healing

Biological Response

Repair of morphology

Return of function