Key Selling Points
15mm Radiopaque Marker Distance
Precise positioning under fluoroscopy for accurate balloon placement in vertebral body. (Source: Model KB0115 specification, 15mm marker distance)
High Burst Pressure ≥400 PSI
Reliable inflation for creating a contained cavity even in dense cancellous bone, reducing risk of balloon rupture. (Source: Constrained burst pressure ≥400 PSI)
Medical-Grade TPU Balloon
Biocompatible, environmental stress-crack resistant, and offers radial support for effective height restoration. (Source: Material specification)
CE-MDR & FDA Cleared
Registered for EU and US markets, ensuring compliance with stringent regulatory requirements. (Source: Certificates CE MDR G100888750012, FDA K223709)
Technical Specifications
| Parameter | Value |
|---|
| Model | KB0115 |
| Distance of Two Radiopaque Markers | 15 mm |
| Channel ID | ≥3.65 mm |
| Overall Length | 315 mm |
| Maximum Volume | 4 cc |
| Constrained Burst Pressure | ≥400 PSI |
| Size/Type | 8G |
Models and Options
KB0115 (15mm) is one of three balloon diameters in the 8G PKP catheter family: KB0210 (10mm), KB0115 (15mm), and KB0120 (20mm). Each model is designed to match different vertebral body sizes and fracture patterns.
Materials and Structure
The balloon is made of medical-grade thermoplastic polyurethane (TPU) with a four-wing pleating design for uniform expansion. The shaft is PU, reinforced with a 06Cr19Ni10 stainless-steel stylet for pushability. A tantalum radiopaque marker band ensures fluoroscopic visibility. Handle components are polycarbonate. The device is EO-sterilized for single use.
Applications
Indicated for the minimally invasive treatment of painful vertebral compression fractures (VCFs) due to osteoporosis, low-energy trauma, or neoplasia (including spinal metastases and multiple myeloma). Also used for symptomatic vertebral hemangiomas. The balloon creates a cavity in cancellous bone, restores vertebral height, and reduces kyphotic deformity, followed by PMMA cement augmentation.
Customization
OEM/ODM customization is available. Contact us to discuss specific requirements for packaging, labeling, or custom kit configurations.
Case Study
Clinical applications include the egg shell technique for VCFs, as reported in Kuwait. Balloon kyphoplasty provides rapid pain relief and height restoration, with patients typically ambulating within 24 hours.
FAQ
What is the difference between the 15mm and 20mm kyphoplasty balloons?
The 15mm balloon (KB0115) has a marker distance of 15mm and a maximum volume of 4cc, while the 20mm balloon has a marker distance of 20mm and a larger volume. The choice depends on the vertebral body size and the extent of fracture reduction required.
Is the KB0115 balloon catheter compatible with standard kyphoplasty tool kits?
Yes, the KB0115 is designed to pair with the Changmei KT-00-01 8G tool kit and the BI-20A-10 balloon inflator (20cc, 30atm) as an integrated system.
What sterilization method is used?
The KB0115 is ethylene-oxide (EO) sterilized and validated for a 3-year shelf life, ensuring sterility until use.
What are the regulatory approvals for this product?
The KB0115 carries CE marking under MDR (EU) 2017/745 and is FDA 510(k) cleared (K223709) for US distribution. It is also manufactured under an ISO 13485:2016 certified quality system.
Can the balloon be used for both thoracic and lumbar vertebral fractures?
Yes, the 15mm balloon is suitable for thoracic and lumbar vertebral bodies, but the physician should select the appropriate balloon size based on preoperative imaging and clinical judgment.
What is the minimum order quantity (MOQ)?
For standard in-stock products, the MOQ is 10 sets. For OEM/ODM customized orders, the quantity is negotiable based on specific requirements.
How is the balloon catheter delivered?
We offer EXW, FOB, and CIF delivery terms. Pre-shipment testing is performed, and full T/T payment is required before shipping.
What is the annual production capacity?
Changmei has an annual production capacity of 1,000,000 balloon catheters, ensuring a stable supply for high-volume procurement.
Inquiry Information
Image: Kyphoplasty-9.jpg - KB0115 balloon catheter product overview
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