PRODUCT SUPPLYThe DEB catheters are supplied sterile and intended for single use only. The DEB catheters are sterilized by ethylene oxide gas. It will remain sterile as long as the packaging remains unopened and undamaged. Use product prior to labeled Expiration Date.CAUTION: Do not use if the inner package is open ordamaged.

SHIPMENT CONDITIONProduct should be shipped, avoiding heavy weight, direct sunlight, snow and rain.

STORAGE CONDITIONThe packed catheter shall be stored in a dry, cool and clean place free of corrosive gases.

INDICATIONSThe drug eluting balloon (DEB) catheters are indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries.

CONTRAINDICATIONS- The DEB catheters are contraindicated for the use in coronary

arteries, supra-aortic vessels and cerebrovascular.- Inability to cross lesion with a guide wire.- The DEB catheters should not be used in pregnant or breast

feeding women or in patients with known hypersensitivity to paclitaxel.

The Longer PatencyThe Longest Journey5-Year Follow-up Results of

the AcoArt I Trial

The first choice forthe treatment of ISR

The long-term benefit of longsegment occlusion is better

The effect is also excellentunder the inner membrane

Reduce/avoid foreignbody implants

WARRANTY/LIABILITYThe product and each component of its system have been designed, manufactured, tested and packaged with all reasonable care. The warnings contained in Acotec’s instructions for use are expressly to be considered as an integral part of this provision. Acotec guarantees the product until the expiry date indicated on the same. The warranty is valid provided that the use of the product was consistent with the instructions foruse.Acotec disclaims any warranty of merchantability or fitness for a particular purpose of the product. Acotec is not liable for any direct, indirect, incidental or consequential damages caused by the product. Except inthe case of fraud or grave fault on Acotec’s part, compensation of any damage to the buyer will not, in any event, be greater than the invoice price of the disputed products. The guarantee contained in this provision incorporates and substitutes the legalguarantees for defects and compliance, and excludes any other possible liability of Acotec, however originating, from the product supplied. These limitations of liability and warranty are not intended to contravene any mandatory provisions of law applicable. If any clause of the disclaimer is considered by a competent court to be invalid or to be in conflict with the applicable law, the remaining part of it shall not be affected and remain in full force and effect. The invalid clause shall be substituted by a valid clause which best reflects Acotec’s legitimate interest in limiting its liability or warranty. No person has any authority to bind Acotec to any warranty or liability regarding the product.

For complete information about this product, please read the product description

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Leads the drug coating technology, establish health milestone Test of time, the curative effect is trustworthy

The results of 5 years of follow-up showed that DCBgroup was better than PTA group in avoiding CD-TLR*

On average, the lesions in AcoArt I group were longer thanthose in similar studies, and the benefit of DCB group fromCD-TLR was more obvious[1, 2]

The 5-year all-cause mortality wassimilar in the DCB and PTA groups Analysis of the cause of death

Subgroup analysis of 5-year follow-up(DCB:89; PTA:91)

Death TLR Death TLR Death TLR

Subgroup of ISR

Rat

e %

Rat

e %

Rat

e %

Subgroup of long lesions Subgroup of CTO

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viva

l rat

e of

enr

olle

d pa

tient

s

value of time series test

K-M curves for all deaths in DCB group and PTA group

Cardiogenic

Cancer

Neurogenic

Renal disease

Respiratory disease

Accident

Unknown reasons

Cardiogenic

Cancer

Neurogenic

Renal disease

Respiratory disease

Accident

Unknown reasons

Regression analysis of mortality factors in the DCB group showed that patients with coronary heart disease andsalvage stent had higher risk, and paclitaxel dose did not increase the risk of death

Death and survival analysis of DCB group

Patient/lesion characteristics Survival Death value

Coronary heart disease (CHD)

Salvage stent

Paclitaxel dose (mg)

free

to C

D-T

LR

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leng

th o

f the

lesi

on

free

to C

D-T

LR

Follow up time, year

The length of the lesion

Follow up time, year

1year 2year 5year

*CD-TLR, Clinical driven target lesion reascularization

DCB PTAC

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