Ronda Medical
Seawon Meditech

SPASY™ — Vertebral augmentation system for compression fractures (VCF)

A cement vertebral augmentation system for vertebral compression fractures (VCF) — combining balloon kyphoplasty (Spinal Alignment System) and vertebroplasty (Bone Cement Dispensing Kit), with full transpedicular access and balloon pressure control via a manometer.

Product gallery
SPASY™ — the complete vertebral augmentation system: the balloon inflation device and the transpedicular access set (Seawon Meditech material)
SPASY™ — the complete vertebral augmentation system: the balloon inflation device and the transpedicular access set (Seawon Meditech material)
SPASY™ — the cement dispensing device (SWDG-4A) with a piston, push handle, and trigger for vertebroplasty (Seawon Meditech material)
SPASY™ — the cement dispensing device (SWDG-4A) with a piston, push handle, and trigger for vertebroplasty (Seawon Meditech material)
SPASY™ — the balloon inflation device (Balloon Expander, SWMP) with a manometer and Lock/Unlock mechanism (Seawon Meditech material)
SPASY™ — the balloon inflation device (Balloon Expander, SWMP) with a manometer and Lock/Unlock mechanism (Seawon Meditech material)
SPASY™ — the bone access needle inserted transpedicularly into the vertebral body (Seawon Meditech material)
SPASY™ — the bone access needle inserted transpedicularly into the vertebral body (Seawon Meditech material)
Kyphoplasty + vertebroplastyTechniques
10 / 15 / 20 mmBalloon sizes
4–6 cm³Balloon volume (max)
TranspedicularAccess
Clinical description

SPASY™ is a complete cement vertebral augmentation system, developed by Seawon Meditech for the minimally invasive treatment of vertebral compression fractures (VCF). The system covers both common percutaneous techniques — balloon kyphoplasty (for restoring vertebral body height and creating a cavity) and vertebroplasty (bone cement injection) — through dedicated kits, assemblable for one or two levels.

The kyphoplasty component (SPASY™ Spinal Alignment System) comprises a balloon catheter available in three sizes (SWS10 / SWS15 / SWS20, with lengths of 10 / 15 / 20 mm and maximum volumes of 4–6 cm³), an inflation device (Balloon Expander, SWMP) with a manometer that indicates the balloon pressure, a release button, and a Lock/Unlock mechanism, plus the complete bone access set: a puncture needle (Bone Marrow Needle, SWMVP, with a slant, beveled, or trocar tip), a guide wire (SWM-1), a working cannula and trocar (SWM-2), a bone drill (SWM-3), and the cement filling device (SWM-4). The technique follows the standard steps: transpedicular access, cavity creation, balloon inflation under fluoroscopic control (C-arm), and cement injection.

The vertebroplasty component (SPASY™ Bone Cement Dispensing Kit) uses a cement dispensing device (SWDG-4A) with a piston, a push handle, and a trigger for fine control of the injection, fed through a hose from the bone access needle available in 11G and 13G (SWVP-11A / SWVP-13A, 125 mm length). The system is intended for vertebral compression fractures of osteoporotic, osteolytic, or metastatic origin.

Indications
  • Vertebral compression fractures (VCF) of osteoporotic origin.
  • Osteolytic fractures of the vertebral body.
  • Metastatic (tumor) vertebral fractures.
Key features

Two techniques in one system

Balloon kyphoplasty (Spinal Alignment System) + cement vertebroplasty (Bone Cement Dispensing Kit).

Balloon with pressure control

The inflation device has a manometer (indicates the balloon pressure), a release button, and a Lock/Unlock mechanism.

3 balloon sizes

SWS10 / SWS15 / SWS20 — lengths of 10 / 15 / 20 mm, maximum volumes of 4–6 cm³, for different anatomies.

Complete transpedicular access set

Bone puncture needle, guide wire, working cannula and trocar, bone drill — for creating the vertebral cavity.

Controlled cement dispensing

The SWDG-4A device with a trigger and piston provides fine control of bone cement injection.

Kits for 1 or 2 levels

Pre-assembled configurations for one level (…-1A) or two levels (…-2A), plus vertebroplasty kits.

Technical specifications
Type
Cement vertebral augmentation system (balloon kyphoplasty + vertebroplasty) for vertebral compression fractures (VCF)
Balloon catheter (SWS10 / SWS15 / SWS20)
Lengths 10 / 15 / 20 mm; maximum pressure ~150 PSI; maximum volume 4 / 4 / 6 cm³; maximum diameter ~17 / 16.3 / 18.5 mm
Inflation device (SWMP)
Balloon Expander with a manometer (indicates the balloon pressure), a release button, and a Lock/Unlock mechanism; filled with ~20 cm³ of contrast agent
Bone access needle (SWMVP)
Bone Marrow Needle with a slant, beveled, or trocar tip; Ø3 mm needle (141 / 106 mm) or Ø2 mm (150 / 110 mm)
Guide wire (SWM-1)
Ø1.5 mm; length 260 mm
Working cannula (SWM-2)
Ø4.3 mm cannula (178 / 144 mm) + Ø3.8 mm trocar (185.5 / 165 mm)
Bone drill (SWM-3)
Ø3.5 mm; length 220 mm
Cement filling — kyphoplasty (SWM-4)
Pusher + filler (Ø3 mm / Ø3.5 mm)
Vertebroplasty kit
SWDG-4A cement dispensing device (with trigger and piston) + 11G / 13G access needle (SWVP-11A / SWVP-13A, 125 mm)
Configurations
Kits for 1 level (SPASY10-1A / 15-1A / 20-1A) or 2 levels (SPASY10-2A / 15-2A / 20-2A); vertebroplasty kits KIT-T4 / T4-1 / T4-2
Device class
CE marking
Manufacturer
Seawon Meditech Co., Ltd., Bucheon, South Korea
Certifications & compliance
CE marking

Product code: SPASY10-1A / 15-1A / 20-1A · SPASY10-2A / 15-2A / 20-2A · KIT-T4 / T4-1 / T4-2

Device class: Marcaj CE