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AcoArt Orchid ®&Dhalia™
AcoArt AVFAcoArt Orchid®&Dhalia™
· Paclitaxel with lipophilic excipient matrix can effectively inhibit endangium hyperplasia and increase the drug transferring rate
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 +33.44 | 25.99 +30.00 | 0.18 |
Hemodialysis Frequency (time/week) | 3 | 3 | 1.00 |
Restenosis (％) | 59.4(82/138) | 57.4(78/136) | 0.73 |
Target Lesion Length | 33.12 土20.89 | 35.25 +22.37 | 0.42 |
Reference Vascular Diameter(mm) | 5.78 0.79 | 5.91+0.78 | 0.17 |
Degree of Stenosis before Treatment(％) | 79.93 +10.26 | 79.38 +12.09 | 0.69 |
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) | 48 | 94 | <0.01 |
Number of Patients Receiving a Second Intervention | 38 | 60 | <0.01 |
Standard Deviation of Average Intervention Times (N=122) | 0.39 土0.72 | 0.77 土0.97 |
DCB has improved safety
| DCB(N=122) | POBA(N=122) | P | |
| Major Adverse Events | 0(0) | 2.5(3) | 0.25 |
| Death | 0(0) | 1.6(2) | 0.50 |
| Stroke | 0(0) | 1.6(2) | 0.50 |
| Pulmonary Embolism | 0(0) | 0(0) | NA |
Compared with similar products, Acotec's DCB group has more significant advantages than the POBA group
Data source: AcoArt AVF clinical trial
| 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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