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.
Guidewire Compatibility :
0.035 inch OTWCatheter Working Length :
75 cm / 100 cm / 135 cmBalloon Diameter :
3.0 mm-12.0 mmBalloon Length :
20 mm-200 mmSterilization :
EOMaejet Peripheral-35 OTW over-the-wire PTA balloon catheter targets PTA angioplasty and stent post-dilatation for medium-to-large peripheral arteries including iliac, femoral, popliteal and renal vasculature.
1.Ultra-slender 0.040-inch tapered atraumatic tip closely fits 0.035-inch guidewires to minimise fish-mouth deformation and enhance navigation across tortuous, severely stenotic lesions.
2.Proprietary tack-weld distal joint strengthens bonding between inner and outer shaft segments for homogenous push-force transfer. It mitigates proximal balloon-bulge phenomenon and improves both advancement and retrieval performance.
3.5-fold semi-compliant balloon folding reduces post-deflation outer profile for better re-crossability, and lessens radial wall stress exerted onto vessel tissue during inflation.
4.Coaxial OTW shaft features enlarged inflation-lumen cross-section compared to conventional dual-lumens, achieving clinically-beneficial rapid deflation. Independent bench testing demonstrates faster deflation metrics vs multiple mainstream competitor devices for identical balloon configurations.
5.Selective hydrophilic coating is applied exclusively to balloon body and distal working shaft while preserving proximal tactile feedback for operators.
6.Specification scope: balloon diameter 3-12 mm; balloon length 20-200 mm; working shaft length 75 cm / 100 cm /135 cm. Nominal Pressure: 8 atm (3-8 mm balloons), 6 atm (9-12 mm balloons). Rated Burst Pressure: 14 atm (3-8 mm),12 atm (9-10 mm), 10 atm (12 mm). Measured average burst pressure ranges from 17-26 atm. Sheath compatibility:5F-7F.
7.Single-use EO-sterilized; re-processing strictly prohibited.
| Guidewire Compatibility | 0.035 inch OTW |
| Tip Outer Diameter | 0.040 inch |
| Catheter Working Length | 75 cm / 100 cm / 135 cm |
| Balloon Diameter Range | 3.0 mm-12.0 mm |
| Balloon Length Range | 20 mm-200 mm |
| Nominal Pressure (NBP) | 8 atm (3-8 mm); 6 atm (9-12 mm) |
| Rated Burst Pressure (RBP) | 14 atm (3-8 mm); 12 atm (9-10 mm); 10 atm (12 mm) |
| Balloon Folding | 5-fold semi-compliant balloon |
| Coating | Selective hydrophilic coating (balloon & distal shaft only) |
| Minimum Sheath Size | 5F / 7F |
| Sterilization | EO |
| Usage | Single Use Only |
Mass-produced within Maejet Class-10,000 peripheral interventional dedicated cleanroom under ISO 13485 full QMS. Each batch undergoes tack-weld joint tensile testing, balloon cyclic inflation-deflation fatigue, inflation-lumen leak-proof validation, coating durability and shaft kink-resistance testing. All balloon-film, polymer shaft and metallic raw materials pass ISO 10993 biocompatibility assessments (cytotoxicity, hemolysis, vascular irritation). Complete batch traceability records are permanently archived, supporting NMPA Class-III registration, EU CE-MDR certification and global peripheral interventional device filing for hospital procurement.
Maejet Peripheral-35 PTA balloon catheters are distributed to vascular surgery departments, interventional radiology wards and global peripheral-vascular medical-device distributors. Long-term bulk customers receive tiered-volume discounts. Large-volume annual orders support custom balloon-length combinations and neutral unbranded OEM packaging. International sales team provides complete regulatory documents: ISO 13485 certificates, CE-MDR technical dossiers, NMPA registration certificates and customs-clearance free-sale certificates. Small clinical trial sample orders are acceptable for hospital pre-clinical validation. Mass-production lead-time: 16-30 working days post deposit confirmation. One-stop cross-border medical-logistics service (consolidated shipment, customs-declaration guidance) can be arranged upon request. Contact dedicated sales representatives for official product catalog, detailed quotation and minimum-order-quantity standards.
The enlarged coaxial inflation lumen shortens complete balloon deflation time. It reduces procedural cycle time during sequential multiple-lesion interventions and improves overall surgical efficiency.
This device is optimised for medium-to-large peripheral arteries. For small-calibre BTK lesions, select Maejet Peripheral-18 (0.018-inch OTW) series instead for better anatomical matching.
Strictly prohibited. Reprocessing damages 5-fold balloon folding geometry and degrades selective hydrophilic coating, which may trigger balloon rupture or poor deflation-retrieval risk in reuse scenarios.
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.
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