AcoArt Orchid ®&Dhalia™

AcoArt AVF

AcoArt AVF

AcoArt Orchid®&Dhalia™

Features

A prospective, multicenter, RCT study




DCB(N=122)POBA(N=122)P

AVF Distribution Position (forearm, ％)

96.7(118)		97.5(119)1.00

AVF Type(Cephalic-radial，％)

93.4(114)94.3(115)1.00

Hemodialysis Access Duration (month)

31.83 +33.4425.99 +30.000.18

Hemodialysis Frequency (time/week)

331.00

Restenosis (％)

59.4(82/138)57.4(78/136)0.73

Target Lesion Length

33.12 土20.8935.25 +22.370.42

Reference Vascular Diameter(mm)

5.78 0.795.91+0.780.17

Degree of Stenosis before Treatment(％)

79.93 +10.2679.38 +12.090.69


Drug-coated Peripheral Balloon Dilation Catheter 国械注准 20163031020


As DCB prolongs the patency time and decreases the re-intervention rate




DCB(N=122)POBA(N=122)P

Primary Patency Rate of TLR within 6 Months

91.4%(106/116)66.9%(79/118)<0.0001

Primary Patency Rate of TLR within 12 Months

66.1%(74/112)46.4%(52/112)<0.01

Cumulative Total Number of Interventions (time)

4894<0.01

Number of Patients Receiving a Second Intervention

3860<0.01

Standard Deviation of Average Intervention Times (N=122)

0.39 土0.720.77 土0.97



AVF 1.jpg


DCB has improved safety


DCB(N=122)POBA(N=122)P
Major Adverse Events0(0)2.5(3)0.25
Death0(0)1.6(2)0.50
Stroke0(0)1.6(2)0.50
Pulmonary Embolism0(0)0(0)NA


Compared with similar products, Acotec's DCB group has more significant advantages than the POBA group

AVF 2.jpg

Data source: AcoArt AVF clinical trial

Technical specifications

Name

Drug-eluting Percutaneous Balloon Dilatation Catheter

Diameter Range(mm)

3/3.5/4/4.5/5/5.5/6/7/8/9/10/12
Length Range(mm)20/30/40/60/80/100/120/150/200/250/300
Guidingwire(inch)0.035

Available Length of Shaft (cm)

45/80/130/150 

Drug Concentration of Paclitaxel (Mg/mm2)

3.3

Coating Matrix Excipient

Magnesium stearate (lipophilic)

Sheath Compatibility

5 - 8
NP(bar)6 
RBP(bar)Max.18 

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