Therapies and procedures

Basivertebral nerve ablation (BVNA)

A minimally invasive option for treating chronic vertebrogenic low back pain.

Indications, Safety, and WarningsViaVerte™ BVNA System Risk Information:INDICATIONS:The ViaVerte™ RF System is intended for Ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). CONTRAINDICATIONS:

Patients with implantable pulse generators (e.g. pacemakers, defibrillators)

Patients with active systemic infection or local infection in the area to be treated

Patients who are pregnant

Skeletally immature patients (generally ≤ 18 years of age)

WARNINGS:

This device should only be used by qualified physicians with training in the clinical procedure in which it is being used.

The physician should have specific training, experience, and thorough familiarity with the use and application of this product.

Do NOT touch the Electrode at the tip of the device while power is being applied.

Do NOT withdraw the device while power is still being applied.

Do NOT touch the Electrode to metal objects while power is being applied, damage to the device may occur.

Use standard electrosurgical precautions when using the device in the vicinity of nerves and nerve roots.

It is essential to maintain strict sterile technique during all phases of handling and use of this product.

Dispose used product per Local, State and Federal blood borne pathogen controls including Biohazard sharps container and disposal procedures.

The product is sterilized by gamma radiation or ethylene oxide gas (for the ViaVerte™ Introducer only). Do NOT use if package is opened or damaged.

All device manipulations (insertion, withdrawal, articulating or straightening of the Articulating Segment or advancing and retracting the device) should be done slowly and under imaging guidance while carefully monitoring the position of the device. When using the ViaVerte™ Ablation Instrument, these manipulations should only be done with the Electrode fully retracted.

Extension and retraction of the ViaVerte™ Ablation Instrument electrode should be done under imaging guidance to monitor the position of the tip of the device.

Ablation procedure must be performed under image guidance. Do NOT perform ablation without first imaging area as it may result in severe injury to patient.

The device must be positioned such that when ablation is performed per the Ablation Zone Dimensions (see Table 2), non-target tissue is beyond the ablation zone. Failure to utilize the ablation zone dimensions in pre-operative planning may result in severe injury to the patient.

Do NOT use flammable anesthetics.

Observe fire precautions at all times. Sparking and heating associated with electro surgery may be an ignition source.

Do NOT rotate the blue handle of the ViaVerte™ Ablation Instrument when the instrument is extended beyond the Working Cannula and articulated, breakage of the device may occur.

The Introducer Stylet should be inserted and engaged with the Working Cannula during Introducer removal or manipulation.

Do NOT apply excessive force when operating the device. It may result in breakage of the device.

Do NOT use this device in patients with multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra.

Do NOT use the PowerCURVE or ViaVerte™ Ablation Instrument in more than one vertebral body

Breakage of the device may require intervention or retrieval. No components of the ViaVerte™ Ablation Instrument should be left behind in the patient. The device has not been evaluated or designed as a long-term implant.

PRECAUTIONS:

It is important to read the Instructions For Use and these precautions prior to device operation.

Use the device prior to “Use By Date” noted on the package.

Do NOT use damaged product. Before use, inspect the device and packaging to verify that no damage has occurred.

Physicians should be familiar with the physiology and pathology of the selected anatomy and be trained in the performance of the chosen surgical technique.

The device should be manipulated only while under fluoroscopic (and/or CT) observation with radiographic equipment that provides high quality images.

Do NOT allow patient contact with grounded metal objects.

As with other electrosurgical units, electrodes and cables can provide paths for high frequency current. Position cables and electrode to avoid contact with the patient or other leads.

The location of the Working Cannula in the vertebra should be confirmed using image guidance before advancement as well as during removal of the PowerCURVE or the ViaVerte™ Ablation Instrument.

Do NOT re-sterilize and/or reuse. The device is for single patient use only. Reconditioning refurbishing, repair, modification, or resterilization of the device to enable further use is expressly prohibited as it will result in device malfunction and/or infection.

Always clean ViaVerte™ RF Generator per the cleaning instructions in the Operators Manual.

The location of the Working Cannula in the vertebra should be monitored under imaging before and during advancement of the PowerCURVE.

POTENTIAL ADVERSE EVENTS:

As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.

Breakage, slippage, misuse or mishandling of Instruments or Probe, such as on sharp edges, may cause burns or injury to the patient or operative personnel.

Nerve injury including thermal injury, puncture of the cord or nerve root potentially resulting in radiculopathy, paresis or paralysis.

Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae.

Hemorrhage.

Hemothorax or pneumothorax.

Hematoma.

Deep or superficial wound infection.

Pain.

Unintended puncture wounds including vascular puncture and dural tear.

Pedicle or vertebral body fracture.

The device tip contains stainless steel components. Potential adverse events that could occur from retained metallic fragments include chronic inflammation, foreign body reaction, infection, migration of fragments, interference with future imaging studies, and potential neurological complications.

A new way to treat vertebrogenic chronic low back pain

Chronic low back pain can affect nearly every part of a patient’s life, work, and daily responsibilities. Basivertebral nerve ablation (BVNA) is a rapidly growing option for patients experiencing chronic low back pain caused by damaged vertebral endplates.

Long-term pain relief^†,1
Minimally invasive
Implant-free

Discover ViaVerte™ BVNA (open in new window)

Who may be a candidate for BVNA?

BVNA may be an option for patients with:

Chronic central low back pain for at least six months
Modic Type 1 or Type 2 changes on MRI
Insufficient relief from conservative treatments, such as physical therapy, medications, and injections. These options need to have been tried for at least six months.

BVNA is not for everyone. Risks may include: surgical complications.

Designed to interrupt pain signals at the source

In appropriately selected patients, the BVNA procedure targets the intraosseous basivertebral nerve within the vertebral body using radiofrequency (RF) energy.

By ablating the nerve, BVNA is intended to reduce transmission of pain signals arising from damaged or inflamed vertebral endplates.

ViaVerte™ ablation product probe without numbers

A new level of control in BVNA

The ViaVerte™ BVNA system is designed to support a more confident approach to vertebrogenic pain treatment, combining precise placement, predictable ablation sizing, and efficient procedure times.^‡,1

Precise | Unparalleled physician-controlled steerability for precise BVN targeting
Predictable | Intraoperative confirmation of the ablation zone when target temperature is reached
Fast | Patient-specific RF ablation time of 5 minutes or less^‡,1

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ViaVerte HCP Brochure (open in new window)

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† 96.5% clinical success rate for pain reduction (defined as a 2-point decrease in patient-reported pain on a 0-10 scale, single-center study, n=56) at 12 months.

‡ Ablation times may vary based on power setting used.

De Vivo AE, et al. Neuroradiology. (2021);63(6):809-815. doi: 10.1007/s00234-020-02577-8