Lepu Medical Cardiovascular Devices Attain Marketing Authorization in Saudi Arabia

1

Partner™ Sirolimus-eluting Coronary Stent System

CE approval, 2 million implantations, Diameter 2.5-4mm, length 12-36mm;

in process

2

H-Stent™ Coronary Stent System

CE approval, Diameter 2.5-4.0mm, length 9-36mm;

in process

3

Nano+™ Polymer-free Sirolimus-eluting Coronary Stent System

China NMPA approval; Diameter 2.5-4.0mm, length 12-36mm;

in process

4

GuReater™ CoCr Sirolimus-eluting Coronary Stent System

China NMPA approval; L605 CoCr Alloy; Diameter 2.5-4.0mm, length 12-36mm;

in process

5

Hoper™ PTCA Balloon Dilatation Catheter

USFDA CE approval; semi-compliant; diameter 1.5-4.0mm, length 9-30mm;Nominal pressure 8atm, RBP 16atm;

Yes

6

Mini-Tadpole™ Coronary Dilatation Catheter

CE Approval; semi-compliant; diameter 1.2-2.0mm, length 6-30mm;

Yes

7

Tadpole™ Coronary Dilatation Catheter

CE Approval; semi-compliant; diameter 2.25-4.0mm, length 6-30mm;

Yes

8

NC Tadpole™ Non Compliant PTCA Balloon Dilatation Catheters

CE approval; high RBP 22atm; hydrophilic distal shaft;diameter 1.5-5.0mm,length 6-30mm

Yes

9

Shoocin™ Introducer Kit FS

USFDA CE approval;Luer Locking System;sheath size 4-11F,length 5cm,11cm;

Yes

10

Shoocin™ Introducer Kit RS

USFDA CE approval;Luer Locking System;sheath size 4-7F,length 5cm,7cm,11cm,24cm;

Yes

11

Brilliant™ Introducer Kit RS

USFDA CE approval;Hydrophilic Guide Wire; Luer Locking System;sheath size 4-7F,length 5cm,7cm,11cm,24cm;

Yes

12

Orien™ Guiding Catheter

CE approval;Curve Type JL, AL, Extra Backup, JR, AR;Size 5F 6F 7F;

Yes

13

Rayband™ Radial Artery Compression Tourniquets

USFDA CE approval;Luer Locking System; 2ml precising deflation design

Yes

14

Angiopower™ Inflation Device

USFDA CE approval;pressure upto 30atm, rapid trigger release, analog/fluorescent pressure display

Yes

15

Ultraskin™ Hydrophilic Guide Wire

USFDA CE approval; Diameter 0.018-0.035; Length 150-260cm; Curve Straight, 135° Angled; Reshapable Tip available;

Yes

16

Balancium Guide Wire

CE approval; Design Core-to-Tip, Shaping Ribbon available; Diameter 0.014; Length 185cm, 300cm; Tip flexibility  0.6g, 1g and 2g available; Tip Shape Straight and J; Moderate Radial Support;

Yes

17

Angioway™ Y-Hemostasis Valve Set

USFDA CE approval; Push-pull/Rotating Type; I.D.: 0.018" (3.0mm); Body Material: polycarbonate; Optional Extension Tubing; Available with Whole Set Package Y Valve+Guide Wire Introducer+Guide Wire Torquer

Yes

18

Angioway™ High Pressure Extension Tubings

CE approval; Large Flow; Customized length available; 500psi / 1200psi; I.D.: 0.056" (1.44mm); Material PVC/TPU

Yes

19

Angioway™ Manifolds

CE approval; Side Port 2/3; Pressure 500psi; Valve Tyepe On/Off; Optional Extension Tubing

Yes

20

Angiospring™ Angiography Control Syringe

CE approval; Solid and Smooth Plunger; Clear Scale; Latex Free; Capacity 12ml; Rotating Connector;

Yes

21

Angiospring™ Contrast Medium Injection Manifold Kits

CE approval; Including Manifold+Angiopraphy Control Syringe+Hige Pressure Extension Tubing+Infusion Set

Yes

22

Supercross™ PTA Balloon Dilatation Catheter

CE approval; Both RX and OTW Available; Semi-compliant ; 2 Markers; Material Nylon 12 and 11; Nominal Pressure 7 atm; Distal Shaft 2.8 Fr; Proximal Shaft 2.3 Fr; Crossing Profile 0.026-0.030"; Usable Catheter Length PTAR 135cm, PTAO 80/135/190cm; Min. Guideing Catheter Compatibility for PTAR 5Fr/0.056"; Introducer Sheath Compatible for PTAO 6F/7F; Guidewire Compatible PTAR-0.014inch, PTAO 0.035inch;

Yes

23

Thromsweeper™ Thrombus Extraction Catheter

CE approval; Rapid Exchange compatibility 6F (0.070") guiding catheter, 0.014" guide wire, length 1450mm, extraction lumen area 1.03 mm², guidewire lumen length 113mm, catheter O.D. Proximal 1.27mm, Distal 1.50mm;

Yes

24

Vesscide™ Cutting Balloon System

China NMPA approval, 3 blades/4 blades, Diameters 2.0-4.0mm, Length 5mm, 10mm and 15mm;

in process