DFINE® Announces Commercial Launch of the Long SpineSTAR® Ablation Instrument for the Palliative Treatment of Metastatic Spine Tumors

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SpineSTAR’s extended working length provides spine specialists greater access and ability to precisely target metastatic spine tumors in order to offer patients rapid, sustained pain relief improving their quality of life.

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“The STAR System has allowed me to treat patients spine tumor related pain in a minimally invasive fashion resulting in significant improvements in pain and quality of life...” -Jack Jennings, M.D., Ph.D.

DFINE, Inc., today announced the commercial launch of its Long SpineSTAR® Ablation Instrument. Long SpineSTAR is the latest innovation by the Silicon Valley medical device manufacturer and is part of the company’s flagship STAR Tumor Ablation System™. The new surgical instrument incorporates new product refinements including a longer working length and a redesigned electrode knob for easier use, enabling the physician to access painful spinal tumors throughout the vertebral body. The STAR System uses radiofrequency or thermal heat to ablate the tumor to achieve rapid and sustained pain relief in a procedure called Targeted-Radiofrequency Ablation (t-RFA).

There are an estimated 280,000 adults in the United States living with metastatic bone disease; with as much as 70% of all cancer patients developing spinal metastases over their lifetime.¹,² These tumors are often extremely painful and debilitating for patients, negatively impacting their quality of life and social functioning with an increased dependence on narcotic pain medication. Targeted-Radiofrequency Ablation (t-RFA) is an advanced minimally invasive treatment that provides a new option for patients to relieve their pain while maintaining compatibility with traditional cancer treatments such as chemotherapy and radiation therapy.

Targeted-Radiofrequency Ablation is an outpatient procedure, performed by spine specialists, most commonly under sedation and local anesthesia. Clinical studies have demonstrated that patients typically experience dramatic, immediate and durable pain relief with >50% of the study patients being able to reduce their use of pain medications.³,⁴ Compared to conventional radiation therapy alone, the combined therapeutic approach of radiofrequency ablation and conventional radiation therapy has been reported to significantly improve patient outcomes by improving the percentage of patients experiencing overall pain response from 60% to over 90%, decreasing time to pain relief (3 vs. 9 weeks), and resulting in less recurrent pain requiring retreatment.⁵

“We developed the Long SpineSTAR to expand the physician’s ability to utilize this technology in larger patients and certain difficult to access vertebrae,” said Greg Barrett, Chief Executive Officer of DFINE. “This is a significant step forward in our mission to dramatically improve the lives of all patients suffering from the pain and loss of function caused by metastatic spinal tumors. Clinical evaluation of the STAR System has resulted in a 77% reduction of pain³ and significant improvement (p<0.01) in patients quality of life.⁶”

The SpineSTAR® Ablation Instrument is the only steerable and navigational radiofrequency device on the market, allowing accurate placement and easy repositioning throughout the vertebral body from a unipedicular approach. The articulating design is built for use in the unique anatomy of the spine to allow physicians easy access to the posterior region of the vertebral body to create site-specific targeted ablation zones.

“The STAR System has allowed me to treat patients spine tumor related pain in a minimally invasive fashion resulting in significant improvements in pain and quality of life,” said Jack Jennings, MD, Associate Professor in Radiology, Director of Musculoskeletal and Spine Intervention, Washington University School of Medicine. “The t-RFA procedure is compatible with traditional cancer therapy, often allowing patients to continue chemotherapy and/or radiation therapy with less discomfort. The Long SpineSTAR’s increased length will allow us to access and treat a broader spectrum of vertebrae and patients.”

The STAR Tumor Ablation system was released in the US in 2012, and has been performed on over 4,000 patients worldwide. The Company is also conducting a number of clinical studies including the prospective, multi-center STAART Study which is currently enrolling patients at leading cancer centers across the United States.

About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR Tumor Ablation System™, represent generational advances in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. For a complete list of risks and indications, visit the DFINE website.

DFINE and StabiliT are registered trademarks of DFINE, Inc.
Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) are trademarks of DFINE, Inc.

1 Li et al. Clinical Epidemiology 2012:487–93
2 Fisher et al. Radiation Oncology 2014, 9:69
3 Anchala et al. Pain Physician. 2014 Jul-Aug; 17(4):317-27.     
4 Hillen et al. Radiology. 2014 Oct; 273(1):261-7.
5 Di Staso et al. Eur Radiol (2011) 21:2004–2010
6 Bagla et al. J Vasc Interv Radiol 2015; 26:e86.

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Susan Smith
DFine, Inc.
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