제노스

Product Introduction

Product

All Genoss products are manufactured in accordance with a systematic
and rigorous quality control system based on ISO standards.

Product Introduction

Vascular Intervention

Angioplasty Catheter, Balloon Dilatation, Coronary, Perfusing

GENOSS™ DCB

Description

- Paclitaxel crystal structure coating of 3μm/mm²
- Uniform coating layer with a thickness of 10μm.
- Excellent drug delivery to target lesion

Product Inquiry

More Information

Features

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

Indicant

Treatment of in-stent restenosis due to stent late lumen loss – Used for Percutaneous coronary intervention (PCI)

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 (%).

Model Name

Stent Diamiter(mm)	10	15	18	20	25	30	35	40
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