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The Ablation Generator System and Ablation Instrument are indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Ablation Generator System is a microprocessor controlled radiofrequency (RF) generator designed for use with the hand held, bipolar, sterile, single use Ablation Instrument for percutaneous delivery of low power bi-polar RF energy by the physician to the tissue site in contact with the Electrode of the Ablation Instrument. The Ablation Instrument is a hand held, bi-polar, sterile, single use device designed specifically for use with the Ablation Generator System. The user connects the Ablation Instrument to the Ablation Generator System using the AE Cable (for delivery of RF energy). The user positions the distal tip of the device containing the active and return electrodes at the tissue site where the specific treatment is to be performed.

StabiliT ER Bone Cement: The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement): The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT ER* Bone Cement: The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component. StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement): StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.

The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. SPACE CpsXL bone cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.

The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.

The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.