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제품소개

Product

제노스의 모든 제품은 ISO 국제표준규격 기반의
체계적이고 철저한 품질관리시스템에 따라 제조됩니다.

풍선확장식관상동맥관류형혈관형성술용카테터
GENOSS DCB
설명
- 3μm/mm² 의 Paclitaxel 결정 구조 코팅
- 균일한 10μm 두께의 코팅층
- 목표 병변까지 약물 전달 성능 우수
상세정보
특징
Drug : Paclitaxel
Drug dose : 3.00㎍/mm²
Coating thickness : Avg. 10㎛
Coating material : Shellac
Coating type : Surface circular coating
Nominal pressure : 8atm(2.00~4.00mm)
Rated burst pressure : 16atm(2.00~3.50mm), 14atm(3.75~4.00mm)
Distal shaft coating : Hydrophilic coating

Distal shaft : 2.5Fr(0.82mm)/2.8Fr(0.92mm)
Proximal shaft : 2.0Fr(0.68mm)
Lesion entry profile : 0.017”(0.43mm)
Usable length : 1450mm
Min. guiding catheter ID : 5Fr(1.42mm),0.056”
Max. guide wire OD : 0.014”(0.36mm)
Catheter type : Rapid exchange
Distal shaft coating : Hydrophilic coating
Distal shaft : 2.5Fr(0.82mm)/2.8Fr(0.92mm)
Proximal shaft : 2.0Fr(0.68mm)
Lesion entry profile : 0.017”(0.43mm)
Usable length : 1450mm
Min. guiding catheter ID : 5Fr(1.42mm),0.056”
Max. guide wire OD : 0.014”(0.36mm)
Catheter type : Rapid exchange
Distal shaft coating : Hydrophilic coating
적응증
스텐트 후기 내강 손실에 의한 스텐트 내 재협착의 치료 - 경피적 관상동맥 중재술(PCI, Percutaneous coronary intervention)에 사용
Serial Quantitative Coronary Angiographic Results at 6 months
GENOSS DCB(n=39) Company A(n=39) P value
Diameter Stenosis in-segment,% 23.5±10.9 30.4±11.2 0.020
Diameter Stenosis in-stent,% 23.5±10.9 30.2±10.8 0.022
Late lumen loss in-segment,mm 0.20±0.50 0.31±0.42 0.353
Late lumen loss in-stent,mm 0.20±0.50 0.33±0.38 0.241
Binary restenosis in-segment,% 0 6.5 (2) 0.164
Binary restenosis in-stent,% 0 3.2 (1) 0.329
Values are mean ± SD or n/N(%).
Clinical Follow-Up at 6 months
GENOSS DCB(n=39) P value
Major adverse cardiovascular events 3 (7.7) 0.020
Cardiac death 0 0.022
Myocardial infarction 1 (2.6) 0.353
Stent thrombosis 0 0.241
Target lesion revascularization 2 (5.1) 0.164
Target vessel revascularization 2 (5.1) 0.329
Values are n (%).
모델명
Balloon
Diamiter
(mm)
Balloon length
10 15 18 20 25 30 35 40
2.00 GDEB-10-200 GDEB-15-200 GDEB-18-200 GDEB-20-200 GDEB-25-200 GDEB-30-200 GDEB-35-200 GDEB-40-200
2.25 GDEB-10-225 GDEB-15-225 GDEB-18-225 GDEB-20-225 GDEB-25-225 GDEB-30-225 GDEB-35-225 GDEB-40-225
2.50 GDEB-10-250 GDEB-15-250 GDEB-18-250 GDEB-20-250 GDEB-25-250 GDEB-30-250 GDEB-35-250 GDEB-40-250
2.75 GDEB-10-275 GDEB-15-275 GDEB-18-275 GDEB-20-275 GDEB-25-275 GDEB-30-275 GDEB-35-275 GDEB-40-275
3.00 GDEB-10-300 GDEB-15-300 GDEB-18-300 GDEB-20-300 GDEB-25-300 GDEB-30-300 GDEB-35-300 GDEB-40-300
3.25 GDEB-10-325 GDEB-15-325 GDEB-18-325 GDEB-20-325 GDEB-25-325 GDEB-30-325 GDEB-35-325 GDEB-40-325
3.50 GDEB-10-350 GDEB-15-350 GDEB-18-350 GDEB-20-350 GDEB-25-350 GDEB-30-350 GDEB-35-350 GDEB-40-350
3.75 GDEB-10-375 GDEB-15-375 GDEB-18-375 GDEB-20-375 GDEB-25-375 GDEB-30-375 GDEB-35-375 GDEB-40-375
4.00 GDEB-10-400 GDEB-15-400 GDEB-18-400 GDEB-20-400 GDEB-25-400 GDEB-30-400 GDEB-35-400 GDEB-40-400