Recently, Lepu Medical’s multiple PCI products received marketing authorization issued by Saudi Food and Drug Authority (SFDA), demonstrating that the authorized products can be marketed and sold to the Kingdom of Saudi Arabia legally.
A total of 12 PCI products received the marketing authorization, covering angiographic catheter, guide wires, introducer sheaths, and accessories. Till date the registration status of cardiovascular series devices of Lepu Medical in Saudi Arabia is as below:
SN. | Product | Features | 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 |
Lepu Medical will keep on addressing the global medical needs by providing high-quality and cost-effective products. For the details and features of the products, please visit: https://en.lepumedical.com/products/cardiovascular-products/
We are now in the stage of building up distribution network, inviting capable channel partners nationwide to join our channel partners’ network, and bring the benefits of Lepu Medical cardiovascular devices and solutions to the patients and cardiologists of Saudi Arabia. Should you have any questions, please feel free to contact marketing@lepu-medical.com.