INDICATIONS, SAFETY, AND WARNINGS
KYPHON™ BALLOON KYPHOPLASTY
RISKS OF BALLOON KYPHOPLASTY AND VERTEBROPLASTY PROCEDURES
As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.
The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related1).
Adverse events potentially associated with use of the Inflatable Bone Tamps (IBT)
- Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae.
- Rupture with fragmentation of the inflatable portion of the IBT resulting in retention of a fragment within the vertebral body.
- Rupture of the IBT causing contrast medium exposure, possibly resulting in an allergic reaction or anaphylaxis.
- Deep or superficial wound infection.
- Retropulsed vertebral body bone fragments which may cause injury to the spinal cord or nerve roots resulting in radiculopathy, paresis or paralysis.
- Bleeding or hematoma
Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:
- Cardiac arrest
- Cerebrovascular accident
- Myocardial infarction
- Pulmonary embolism
- Cardiac embolism
Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:
- Deep or superficial wound infection
- Fistula
- Hematoma
- Hemorrhage
- Heterotopic new bone formation
- Extravasation of bone cement potentially resulting in but not limited to:
- Compression or irritation of nerve structures, such as the spinal cord or nerve roots, causing radiculopathy, paresthesia, paraplegia or paralysis and/or;
- Introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae
- Pyrexia due to allergy to bone cement
- Short-term conduction irregularities
- Thrombophlebitis
- Transitory fall in blood pressure
Inflatable Bone Tamps (IBT) – Indications for Use
Kyphon Xpander™ and Kyphon Express™ Inflatable Bone Tamps (IBT) are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty), hand, tibia, radius, and calcaneus.
Bone Cement – Indications for Use
Kyphon Xpede™ Bone Cement and Kyphon HV-R™ Bone Cement are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
Kyphon ActivOs™ 10 Bone Cement with Hydroxyapatite is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.
Kyphon HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
REFERENCE
1.Quantitative analysis of perioperative complication rates in balloon kyphoplasty and vertebroplasty (meta-analysis). Medtronic Spine LLC; 2006 December 11, 2006. [95000047]
INDICATIONS, SAFETY, AND WARNINGS
OSTEOCOOL™ RF ABLATION PROBE KIT
INDICATIONS FOR USE
The OsteoCool™ RF Ablation Probe Kit, in combination with other components of the OsteoCool RF Ablation System, is intended for:
- Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
- Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
- Ablation of benign bone tumors such as osteoid osteoma.
CONTRAINDICATIONS
- Use of the OsteoCool RF Ablation System device is contraindicated in vertebral body levels C1-C7.
WARNINGS
- The OsteoCool RF Ablation Probe Kit contains single use devices. They should not be re-sterilized or re-used. Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another.
- Take appropriate precautions for patients with blood coagulation disorders, anticoagulant use, neurological deficit, or systemic infection or local infection in area of the procedure.
- The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state for patient feedback.
- Adequate measures must be taken to minimize x-ray exposure while using fluoroscopy. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Do not modify the equipment as this may compromise safety and efficacy.
- When the OsteoCool RF Generator is activated, electrical fields may interfere with other electrical medical equipment.
- During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.
- Discontinue use if inaccurate, erratic, or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury.
- For safe use of the OsteoCool RF Ablation System, the physician should have specific training, experience, and through familiarity with the use and application of this product.
- Do not ablate in painful osteoporotic vertebra without tumor.
- Do not use the device in fractures due to prostatic cancer or other osteoblastic metastases to the spine.
- Do not use the products in dense (sclerotic) bone including traumatic high energy fracture as device damage resulting in patient injury may occur.
- Do not use this device in patients without metastatic malignant lesions in bone or in the vertebral body.
- When using this device in the vertebral body, do not use this device in patients with multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra.
- Do not use this device in more than one vertebral body.
- Do not touch the electrode tip while power is being applied.
- Do not withdraw the OsteoCool RF Ablation Probe while power is being applied to ablate lesions.
- Use standard electrosurgical cautions when using the OsteoCool RF Ablation System in the vicinity of nerves and nerve roots.
- Ablation must be performed under fluoroscopic guidance. Do not perform ablation without imaging as it will result in severe injury to the patient.
- When using this device in the vertebral body, the OsteoCool RF Ablation Probe must be positioned within the vertebral body such that when ablation is performed per the thermal distribution graphs, nerves and nerve roots are beyond the ablation zone. Failure to follow the thermal distribution graphs will result in severe injury to the patient.
- Precautions during ablation near organ surface or near vasculature – Due to the non-homogenous conduction and convection of heat in this anatomy, shapes of ablations performed on tissue that is near the organ surface or near vasculature may not be spherical. Careful planning should be done for targets that require ablation in these locations.
- Any application or procedure that alters tissue perfusion and affects temperature elevation should be monitored carefully.
- High power settings can cause local desiccation of tissue, which can impede the ability to produce expected ablations. Set power as low as possible for intended purpose. Follow manufacturer’s guidelines of time at temperature for ablation generation. If the recommended times and temperatures are not achieved there can be no assurance that the desired ablation volume has been created. Standard techniques for evaluation (e.g. CT or MRI) should be used to determine the actual extent of all ablations.
- It is important to carefully evaluate all candidates for this procedure for evidence of impending fracture, particularly in weight-bearing bone. Do not perform RF ablation of metastases in weight-bearing bone with evidence of impending fracture. Note: Pathologic fracture is more prevalent and serious in long bone.
- It is important to carefully evaluate all candidates for this procedure for proximity of the metastasis to critical structures. Ensure that device placement is at least 1cm away from the structures not intended for ablation. Proximity to nerve structures is particularly critical. Serious complications such as incontinence can occur if these critical structures are damaged during the RF ablation procedure.
- The durability of pain relief after using this device to ablate painful bone metastases has not been established.
- Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.
PRECAUTIONS
Do not attempt to use the OsteoCool RF Ablation Probe Kit before thoroughly reading the accompanying Instructions for Use and the user manual for the OsteoCool RF Generator.
- Only physicians familiar with RF lesion techniques should use the OsteoCool RF Ablation Probe Kit components.
- Do not modify the kit components, including bending and removing insulation.
- Use care when handling the devices.
- Proper sterile techniques must be used when assembling and filling the OsteoCool Tube Kit. Do not place the lid down on a non-sterile surface.
OsteoCool RF Ablation Probe
- The OsteoCool™ Tube Kit should never be disconnected from the OsteoCool™ RF Ablation Probe when RF delivery is in progress. The lumen of the tube kit should not be obstructed in any way during the procedure, as this will stop cooling of the probe.
- Disconnect the OsteoCool™ RF Ablation Probe by pulling the connector, not the cable.
- Handle the OsteoCool™ RF Ablation Probe safely when it is in use due to electric currents and the hot tip.
- Do not bend the OsteoCool™ RF Ablation Probe as this may damage the insulation.
- Do not remove or withdraw the OsteoCool™ RF Ablation Probe while energy is being delivered to ablate lesions.
- While inserting the OsteoCool™ RF Ablation Probe through the Introducer watch the fluoroscope for any buckling. Do not attempt to further insert the probe if any buckling is observed or significant resistance is felt.
- Do not move the Introducer when the OsteoCool RF Ablation Probe is in it. If repositioning is needed, retract the probe from the introducer and then reposition the introducer with the stylet inserted.
- The physician must determine, assess, and communicate to each individual patient all foreseeable risks of the RF procedure.
- The “Temperature” displayed on the generator while in “Ablate” refers to the cooled electrode temperature and not the hottest tissue temperature.
Introducer (not supplied)
Introducers must be 13 Gauge or larger, and have a length such that the proximal electrode on the probe is extended at least 5mm beyond the distal margin of the introducer.
OsteoCool Tube Kit
- The OsteoCool Tube Kit is for use with a single OsteoCool RF Ablation Probe.
- Care must be taken to ensure all luer fittings are secure to prevent leaking. Do not disconnect luer fittings while the pump is running.
- Arrange equipment to minimize tubing tripping hazards.
- Do not complete cooled RF lesion procedures if water is not circulating through the Tube Kit, water is leaking, or air bubbles are seen in the tubing. Immediately stop the procedure and correct circulation before restarting the procedure.
- Do not pinch the tubing of the OsteoCool Tube Kit.
ADVERSE EVENTS
The OsteoCool™ RF Ablation Probe Kit is used with other components of the OsteoCool™ RF Ablation System in RF lesion procedures. Adverse events associated with the use of this device are similar to those indicated for medicated and anesthetic methods utilized in other surgical procedures.
- As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.
- Nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis.
- Pulmonary embolism.
- Hemothorax or pneumothorax.
- Infection including deep or superficial would infection.
- Unintended puncture wound including vascular puncture and dural tear.
- Hemorrhage.
- Hematoma.
- Pain.
PATIENT SELECTION CRITERIA
Candidates suitable for RF ablation procedures with the OsteoCool RF Ablation System include:
- Patients experiencing significant pain from metastases involving bone.
- Patients with localized pain resulting from not more than two sites of metastatic disease.
- Patients that do not have evidence of impending fracture.
Patients should be examined prior to the RF ablation procedure to determine the focal site(s) of pain. The following should be used to help guide therapy and define the area that is intended for RF ablation:
- Location of most significant pain.
- Pre-operative image scans to correlate with the patient physical exam and patient symptoms.
- The extent of bone surrounding the tumor(s) to aid in selecting ablation parameters.
The size, shape, and location of the metastatic lesion in the patient will determine the number of ablations required.
Per the Indications for Use, the device is intended for:
- Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
- Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Standard therapy is defined per relevant medical society guidelines on treatment of metastatic lesions involving bone. For guidance, please refer to applicable medical society guidelines.
INDICATIONS, SAFETY, AND WARNINGS
ACCURIAN™ RF ABLATION SYSTEM
For safe use of the ACCURIAN™ RF Ablation System, the physician should have specific training, experience, and thorough familiarity with the use and application of this product.
DESCRIPTION
The Generator is a four-channel radiofrequency ablation platform that allows monopolar deliveries with a dispersive electrode as well as bipolar deliveries between probes. RF energy is applied to the patient according to the configured settings to create lesions in tissue. The generator is capable of stimulating nerve cells by delivering low frequency stimulation pulses. It is nonsterile and reusable.
INDICATIONS
The ACCURIAN™ RF Generator is intended for the creation of radiofrequency lesions in nervous tissue.
CONTRAINDICATIONS
Use of the ACCURIAN™ RF Ablation System is contraindicated in patients with systemic infection or local infection in the area of the procedure.
WARNINGS
DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient while operating the ACCURIAN™ RF Ablation System. If the patient has a spinal cord, deep brain, or other stimulator, contact the manufacturer to determine if the stimulator needs to be in the OFF position. The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state for patient feedback; general anesthesia is not recommended. Adequate measures must be taken to minimize x-ray exposure while using fluoroscopy. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Do not modify the equipment as this may compromise safety and efficacy. When the ACCURIAN™ RF Generator is activated, electrical fields may interfere with other electrical medical equipment. Ablation must be performed under fluoroscopic or ultrasonic guidance. Do not perform ablation without imaging as it can result in severe injury to the patient. Observe appropriate fire and electrical cautions at all times when system is in use.
ADVERSE EVENTS
As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury can occur. Nerve injury including thermal injury, or puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis. Potential complications include but are not limited to: infection including deep or superficial wound infection, bleeding, nerve damage, visceral injury, increased pain, pulmonary embolism, hemothorax or pneumothorax, hemorrhage, and hematoma.
For a complete description of the Warnings, Precautions, and possible Adverse Events associated with the ACCURIAN™ RF Ablation System, please see the following User Manuals: ACCURIAN™ Connector Hub, ACCURIAN™ Enhanced RF Probe Kit, ACCURIAN™ Pump Unit and ACCURIAN™ Pump Cable, ACCURIAN™ RF Cannula, ACCURIAN™ Radiofrequency Generator, ACCURIAN™ Reusable RF Probe, and ACCURIAN™ Single-Use RF Probe.
