Overview
The Spinery® Generator is a radiofrequency (RF) thermal ablation system designed for vertebral ablation procedures and pain relief in patients with bone metastases. It integrates graphical control and real-time monitoring of operating parameters (impedance, power, and temperature), together with a closed-loop cooling circuit connected to a peristaltic pump.
Main Features
Customization of the ablation modality according to the clinical scenario.
Continuous graphical monitoring of impedance, power, and temperature, with safety sensors that automatically stop the procedure when preset thresholds are reached.
Progressive heating profiles to ensure uniform heat distribution and reduce the risk of tissue carbonization.
Automatic cooling at the end of the procedure to restore baseline temperature and facilitate subsequent steps (e.g., cement injection).
Integrated peristaltic pump for probe irrigation/cooling circuit management.
Accessories
Operation requires the use of sterile single-use accessories: the Spinery® Kit, which includes the RF probe, irrigation components, and percutaneous bone access tools, and the Spinery® Cooling Connection, which enables continuous cooling through the integrated peristaltic pump. Connections include electrical interfaces for the probes, cooling lines, and irrigation systems.
Indications for Use
The Spinery® RF Generator, in combination with sterile single-use accessories, is indicated for thermal ablation and pain relief in patients with spinal metastatic tumors and for ablation in bone structures (vertebrae, sacrum, ilium, acetabulum). It supports single-probe or dual-probe procedures (parallel or crossed) depending on lesion size, location, and clinical strategy.
Features / Technical Specifications
External generator dimensions: Height 340 mm, Width 320 mm, Depth 340 mm.
Generator weight: 10 kg.
Probe gauge: 16G; bipolar, cooled and irrigated probes with dual thermocouples (distal and proximal).
Monitoring: impedance, power, temperature (graphical display and safety sensors with automatic shutdown).
Pump: integrated peristaltic pump for closed-loop cooling/irrigation circuit.
Ablation type: progressive heating profiles with automatic post-procedure cooling.
Accessory sterilization: EtO (ISO 11135:2014 referenced for some accessories).
Risk classification: Class IIb medical device.