Multi-Fold PTCA Balloon Dilatation Catheter

Product Overview

As a universal single-use interventional dilatation device, its core advantage lies in ultra-thin folded balloon construction. High-temperature shaping drastically reduces folded volume for smooth navigation through bifurcated, tortuous and mildly calcified stenotic vessels. The tip is manufactured via bidirectional laser smooth fusion without sharp edges, drastically cutting risks of intimal dissection and perforation. Dual push rod designs accommodate diverse operator habits: the simplified coaxial model fits straightforward single-vessel lesions, while the dual-lumen rapid-exchange version avoids full wire retrieval to shorten multi-lesion operation time. Only the distal working segment is coated with hydrophilic lubricant, reserving distinct tactile feedback on the proximal shaft for precise push control. Balloon lengths span 6–200mm for focal short stenosis and long serial vascular lesions. The kink-resistant shaft withstands standard angioplasty pressure, yet it is not indicated for severe fibro-calcified plaques (select ultra-high pressure balloon series for heavy calcification). Single EO ethylene oxide sterilization is applied; all forms of reprocessing are prohibited.

Key Highlights

• Minimal Entry OD 0.0158” Tip: exceptional navigability through narrow lesions.
• Multi-Fold Heat Treated Balloon Technology: excellent crossing and re-crossing performance.
• Dual Push Rod Configurable Structure.
• Segmented Distal Hydrophilic Coating: smooth dilation.

Technical Specifications & Construction

Typical Clinical Applications

• Percutaneous Transluminal Coronary Angioplasty (PTCA) for mild/moderate coronary stenosis
• PTA balloon dilatation of femoral, tibial & iliac peripheral arterial lesions
• Minimal dilation of non-calcified mild intracranial vascular stenosis
• Pre-dilation preparation before bare metal & drug-eluting stent implantation
• Short-segment mild renal artery stenosis minimally invasive intervention

Quality Assurance & Compliance

Produced inside 7,000㎡ Class 10,000 interventional cleanroom under full ISO13485 QMS. Every production batch undergoes targeted durability testing including balloon cyclic inflation, shaft torsion fatigue and coating friction resistance. All balloon membrane and polymer shaft raw materials complete ISO 10993 biocompatibility tests covering cytotoxicity, hemolysis and skin irritation. Permanent raw material batch archives are stored to support NMPA Class III, EU CE MDR and US FDA cardiovascular medical device registration applications worldwide.

Ordering Information

This PTCA balloon catheter is distributed to tertiary cardiac catheter labs, neurointerventional wards, peripheral vascular surgery departments and global interventional medical distributors. Long-term bulk partners gain tiered volume discounts; custom balloon size combinations, exclusive shaft lengths and neutral unbranded OEM packaging are available for large-volume long-term orders. Our overseas sales team delivers complete regulatory files including ISO13485 certificates, CE MDR technical dossiers and customs clearance free-sale certificates. Small clinical trial sample orders are supported; mass production lead time is 15–28 working days post deposit confirmation. One-stop cross-border medical logistics solutions (consolidated shipment, customs guidance) are provided upon request. Contact dedicated sales staff for official catalog, detailed quotation and MOQ standards.

Frequently Asked Questions (FAQ)