Maejet Peripheral-18 is an over-the-wire (OTW) peripheral balloon catheter compatible with 0.018-inch guidewires. It features proprietary tapered-profile balloons matching the natural tapering anatomy of below-the-knee (BTK) arteries. The 0.020-inch bidirectional laser-formed atraumatic tip and tack-weld reinforced shaft deliver superior crossability and retrievability across tortuous long lesions. Selective hydrophilic coating on the balloon body minimizes advancing friction. Offering balloon diameters from 1.5-6.0 mm, this device supports angioplasty for long stenotic or occlusive lesions above and below the knee, optimising vessel preparation and lowering dissection risks.
Guidewire Compatibility :
0.018 inch OTWCatheter Working Length :
90 cm / 150 cmBalloon Diameter :
1.5 mm-6.0 mmBalloon Length :
20 mm-200 mmSterilization :
EOThis OTW PTA balloon catheter is engineered for vessel preparation in peripheral arterial disease (PAD), with primary focus on long multi-segment stenoses and occlusions in below-the-knee (BTK) vasculature.
1. The 0.020-inch bidirectional laser-shaped atraumatic tip closely mates with 0.018-inch guidewires and reduces fish-mouth deformation.
2. A proprietary distal tack-weld joint reinforces inner-outer shaft bonding for uniform force transmission, preventing the proximal-bulge phenomenon caused by inefficient push transfer and improving both crossing and retrieval performance.
3. The portfolio includes standard cylindrical balloons and anatomically-matched tapered balloons (0.5 mm or 1 mm proximal-to-distal diameter step). Balloons of 1.5-5.0 mm adopt 3-fold folding; 6.0 mm balloons adopt 5-fold folding, shrinking post-deflation profile for better re-crossability.
4. Proprietary selective hydrophilic coating is applied only to balloon body and distal working shaft to maintain tactile feedback on proximal segments.
5. Available working shaft lengths: 90 cm & 150 cm; balloon diameter 1.5-6.0 mm; balloon length 20-200 mm; total 29 tapered-balloon configurations.
6. Nominal Burst Pressure (NBP): 8 atm; Rated Burst Pressure (RBP):14 atm; measured average burst pressure ranges 21-28 atm depending on balloon diameter.
7. Sheath compatibility: 4F minimum for balloons ≤4.0 mm, 5.0 mm (≤80 mm) and all tapered variants; 5F minimum for 5.0 mm (≥100 mm) and 6.0 mm balloons. Single-use EO-sterilized; reprocessing is strictly prohibited.
| Guidewire Compatibility | 0.018 inch OTW |
| Tip Outer Diameter | 0.020 inch |
| Catheter Working Length | 90 cm / 150 cm |
| Balloon Diameter Range | 1.5 mm-6.0 mm |
| Balloon Length Range | 20 mm-200 mm |
| Nominal Pressure (NBP) | 8 atmospheres (atm) |
| Rated Burst Pressure (RBP) | 14 atmospheres (atm) |
| Balloon Folding | 3-fold (1.5-5.0 mm); 5-fold (6.0 mm) |
| Coating | Selective hydrophilic coating (balloon & distal shaft only) |
| Minimum Sheath Size | 4F / 5F |
| Sterilization | EO |
| Usage | Single Use Only |
Mass-produced in Maejet Class-10,000 dedicated peripheral interventional cleanroom, operated under full ISO 13485 QMS framework. Each production batch executes dedicated performance validation: tack-weld joint tensile test, balloon cyclic inflation-deflation fatigue, coating adhesion and shaft kink-resistance testing. All polymer tubing, balloon film and metallic component raw materials pass ISO 10993 biocompatibility assessments including cytotoxicity, hemolysis and vascular irritation. Full batch traceability archives are permanently stored, supporting NMPA Class-III, EU CE-MDR and global cardiovascular device registration submissions.
Maejet Peripheral-18 PTA balloon catheters are supplied to vascular surgery departments, limb-ischemia stroke centers and worldwide peripheral interventional medical distributors. Long-term bulk partners qualify for tiered volume-based discounts. Large-volume annual orders support customised balloon-length selections, exclusive tapered-balloon configurations and neutral unbranded OEM packaging. Our international sales team delivers complete regulatory dossiers: ISO 13485 certificates, CE-MDR technical files, NMPA registration documents and free-sale certificates for customs clearance. Small clinical trial sample orders are accepted for hospital pre-procedure validation. Mass-production lead-time:16-30 working days after deposit confirmation. One-stop cross-border medical-logistics solutions (consolidated shipment, customs-declaration guidance) are available upon request. Contact dedicated sales staff to obtain official catalog, detailed quotation and MOQ standards.
Tapered balloons are recommended for anatomically tapering BTK long-segment lesions, to avoid over-distension of smaller distal vessel segments and reduce arterial dissection probability. Cylindrical balloons fit uniform-diameter short focal lesions.
The tack-weld reinforces distal inner-outer shaft connection. It prevents the proximal balloon-bulge defect caused by inefficient push-force transfer during advancement, improving safety when navigating tight stenoses.
Strictly prohibited. Reprocessing will degrade selective hydrophilic coating and damage multi-fold balloon folding geometry, leading to balloon rupture or poor re-crossability during clinical reuse.
Maejet Peripheral-35 is an over-the-wire (OTW) PTA balloon catheter compatible with 0.035-inch guidewires. It features an ultra-slender 0.040-inch atraumatic tip and proprietary tack-weld reinforced shaft, delivering superior pushability and lesion-crossing performance for medium-to-large peripheral vessels including iliac, femoral and popliteal arteries. Its 5-fold semi-compliant balloon pairs with selective distal hydrophilic coating. The coaxial large inflation lumen enables industry-leading rapid deflation performance. Balloon diameters range from 3-12 mm; working shaft lengths 75 cm /100 cm /135 cm. Indicated for stenoses & occlusions of iliac, femoral, popliteal, renal arteries as well as peripheral stent post-dilatation procedures.
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