STAR

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http://dfineinc.com/star/

Radiofrequency Ablation System (RFA) is an that was safely and effectively used in the treatment of spine metastatic osseous lesions. This device allows RFA treatment of previously untreatable lesions with resultant reduction in pain that was not controlled by systemic or radiation therapy 1).

While any patient with focalized pain from a metastatic spinal tumor may be a candidate for t-RFA, several specific patient groups will likely benefit most from the procedure.

These include patients…

with radio-resistant tumors.

with recurrent pain after radiation therapy.

with posterior vertebral body metastatic tumors.

who have reached their maximum radiation dose limit.

with localized pain and symptoms that are preventing palliative radiation.

who cannot undergo other palliative treatments due to current systemic treatments.

in which myelosuppression is of concern.

“The spine tumor ablation procedure is particulary helpful for those patients who have a type of tumor that is radiation therapy resistant.

Rapid pain relief + localized tumor destruction

For localized bone pain, such as that associated with painful metastatic spinal lesions, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines indicate that radiofrequency ablation should be a considered treatment option.*

Oncologists and cancer care team members recognize the fast and durable pain relief patients achieve with minimally invasive targeted radiofrequency ablation (t-RFA).

Single Treatment

Using the STAR Tumor Ablation System, t-RFA delivers meaningful pain relief and localized tumor destruction in a single treatment, often in an outpatient setting.

Control With the STAR System, physicians have the control to create site-specific ablation zones and monitor real-time ablation zone development within the vertebral body.

Compatible Compatible with systemic therapies, t-RFA expands the range of treatment options for patients with painful spinal tumors.

Meaningful Clinical Outcomes Clinical data show that rapid and lasting pain relief from metastatic spinal tumors is a reality for patients who receive t-RFA using the STAR System. This multicenter retrospective study included 128 treated lesions in 92 patients, many of whom had failed radiation therapy. Pain was decreased by 77% and 54% of the patients were able to reduce pain medication usage after t-RFA.*

Rapid Pain Relief

The STAR System enables a single, minimally invasive procedure that can provide rapid, durable pain relief and localized tumor destruction.

Treatment Compatibility t-RFA is non-toxic, thereby allowing patients to continue their current systemic treatment uninterrupted.

Increased Options

The STAR System offers a treatment path for patients with limited options, including those with radio-resistant tumors or who have reached their radiation dose limits.

Targeted therapy for fast, local control

The SpineSTAR Ablation Instrument is uniquely designed specifically for use in the complex anatomy of the spine. This small steerable device is inserted into the vertebra to deliver targeted RF energy to the tumor. RF energy heats and destroys metastatic tumor cells, while temperature sensors within the SpineSTAR continuously monitors the ablation zone progress to minimize patient risk. Additionally, the instrument is created with a coaxial lumen to facilitate biopsy or injection of cement if indicated without removing the cannula.

A desirable combination of therapeutic advantages for your patients

STAR 1 Device placed

STAR 2 RF energy delivered

STAR 3 Tumor ablated

Risks and Contraindications As with most surgical procedures, there are risks associated with the STAR procedure, including serious complications. For complete information regarding risks, contraindications, warnings, and precautions, please review the systems’ Instruction for Use.

1)
Anchala PR, Irving WD, Hillen TJ, Friedman MV, Georgy BA, Coldwell DM, Tran ND, Vrionis FD, Brook A, Jennings JW. Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study. Pain Physician. 2014 Jul-Aug;17(4):317-27. PubMed PMID: 25054391.