Balloon catheter spine augmentation system PVP

access sheathdrillbone cement syringe

Overview
ZorayPT PVP KIT is a custom disposable kit designed for percutaneous vertebroplasty and related spinal augmentation procedures. The kit is precision-engineered for single-use and is produced in an ISO 13485-certified Class 100,000 cleanroom. Materials include medical-grade stainless steel, nitinol (guide wire option) and medical-grade plastics for components such as the Bone Cement Applier.

Kit Components

• Percutaneous Access Device — 2.5 mm–4 mm diameter, 100 mm–150 mm length
• Guide Wire — 0.8 mm–1.2 mm diameter, 300 mm–600 mm length (nitinol option)
• Expansion Cannula — 3 mm–5 mm diameter, 100 mm–150 mm length
• Bone Drill — 3 mm–5 mm diameter, 100 mm–150 mm length, twist flute, trocar tip, T-handle
• Balloon Filling Device — 10 mL–30 mL capacity, up to 30 atm, Luer lock
• Bone Cement Applier — manual push, 1 mL–5 mL per push, total 20 mL–30 mL, Luer lock compatible

Key Features

• Materials: medical stainless steel; nitinol option for guide wire; medical-grade plastics for the cement applier; components customizable
• Access Device: sharp beveled or diamond tip options; radiopaque markings for positioning
• Guide Wire: flexible, kink-resistant construction with atraumatic tip
• Expansion Cannula: smooth inner lumen to facilitate cement flow; radiopaque marking
• Bone Drill: twist flute geometry and trocar tip for controlled entry; ergonomic T-handle; single-use
• Balloon Filling Device: precise inflation control, up to 30 atm, Luer lock connection
• Bone Cement Applier: manual push delivery, configurable push volume, Luer lock compatible
• Single-use design with OEM/ODM customization available to meet clinical specifications

Applications

• Percutaneous vertebroplasty — cement delivery for vertebral compression fractures
• Spinal stabilization in osteoporosis or metastatic bone disease
• Pain relief interventions related to vertebral fractures and structural augmentation

Manufacturing & Capabilities
One-stop OEM/ODM production with in-house plastic molding, metal processing and cleanroom assembly in an ISO 13485 environment. Advanced processes available include grinding, marking, bending, drilling, head forming, taper reduction/flaring, threading, chamfering, flanging, grooving, flattening, diameter changes, polishing/coating, syringe base and mold production, and die-casting mold work.

PVP KIT Specifications

• Percutaneous Access Device: 100 mm–150 mm length; 2.5–4 mm diameter; sharp beveled or diamond tip; radiopaque markings; customizable
• Guide Wire: 300 mm–600 mm length; 0.8–1.2 mm diameter; flexible, kink-resistant, atraumatic tip; nitinol option; customizable
• Expansion Cannula: 100 mm–150 mm length; 3–5 mm diameter; smooth inner lumen; radiopaque marking; customizable
• Bone Drill: 100 mm–150 mm length; 3–5 mm diameter; twist flute, trocar tip, T-handle; single-use; customizable
• Balloon Filling Device: 10–30 mL capacity; up to 30 atm pressure; precise control; Luer lock; customizable
• Bone Cement Applier: 1–5 mL per push; total 20–30 mL capacity; manual push delivery; Luer lock compatible; customizable

Technical Specifications

• Single-use PVP KIT for percutaneous vertebroplasty
• Materials: medical stainless steel, nitinol (guide wire option), medical-grade plastics
• Access Device dimensions: 2.5–4 mm diameter; 100–150 mm length
• Guide Wire dimensions: 0.8–1.2 mm diameter; 300–600 mm length; kink-resistant
• Expansion Cannula dimensions: 3–5 mm diameter; 100–150 mm length; smooth inner lumen
• Bone Drill: twist flute design with trocar tip; single-use; T-handle
• Balloon Filling Device: 10–30 mL capacity; up to 30 atm; Luer lock
• Bone Cement Applier: manual push, 1–5 mL per push; total 20–30 mL; Luer lock compatible
• Produced in ISO 13485 Class 100,000 cleanroom
• Customizable design options available to meet specific clinical specifications or samples