Paradigm Spine Awarded Approval for Stenosis Treatment Device

Paradigm Spine LLC has been granted U.S. Food and Drug Administration approval for Coflex, a minimally invasive motion preserving interlaminar stabilization device for the treatment of moderate to severe stenosis with or without back pain.

According to Paradigm, this is the first pre market approval of any treatment for this type of stenosis. The company conducted an investigational device exemption (IDE) study that evaluated pedicle screw fusion following surgical decompression, the current standard of care for the treatment of moderate to severe spinal stenosis, as the control. Coflex reportedly demonstrated better or equivalent outcomes in all major primary and secondary endpoints.

Data showed that Coflex patients spent 40 percent less time in the hospital than fusion patients. Coflex surgeries were 36 percent faster. At two years follow up, 85.8 percent of Coflex patients showed clinically significant improvement in pain and function (measured by the Oswestry Disability Index, a standardized measurement system for pain and physical hindrance), compared to 76.7 percent of fusion patients. After two years, Coflex patients also maintained range of motion better than fusion patients.

“This study provides the evidence insurance companies, surgeons, and patients have been demanding,” said Marc Viscogliosi, Paradigm’s chairman and CEO. “Insurance companies, surgeons, and patients finally have an alternative to fusion which, based on independent study data, has demonstrated that Coflex produces better outcomes, a faster recovery, preserves motion, and may be performed on an outpatient basis. For patients, the ability to walk without back pain and the progressive symptoms of stenosis is one of the most cherished functions of the aging population.”

The study results were based on data evaluated from 322 patients at 21 sites throughout the United States, who presented with a history of spinal stenosis that failed over six months of conservative therapy. The study included a significant number of Medicare-aged patients—according to the American Association of Neurological Surgeons, spinal stenosis is a condition most commonly caused by degenerative changes of the spine in people age 60 and older.

Though Coflex is only now gaining approval in the United States, the device has more than 18 years of clinical history with regulatory approval in over 40 countries.

According to a Wall Street Journal analysis of data compiled by the Centers for Medicare & Medicaid Services, it is estimated that fusion costs the United States government Medicare system more than $2.2 billion annually. Paradigm claims that the Coflex procedure saves the healthcare system an average of $5,000 to $8,700 per case when used as an alternative to pedicle screw fusion. These substantial cost savings were achieved through significantly shorter operating room time, faster patient recovery, less blood loss, less narcotics usage by patients, and shorter hospital stay, while producing faster and more sustained clinically successful outcomes as compared to fusion in the treatment of spinal stenosis.

“This is the first time a new spinal technology is proven to be better and more effective than the historical gold standard, and is still actually lower cost,” said Reginald Davis, M.D., principal investigator for the Coflex study. “I am excited to be able to provide Coflex to my patients without the need for fusion through a simple, motion preserving, and minimally invasive bone-saving surgical technique.”

“Although outcomes for pedicle screw-based fusions have been historically acceptable, it was the only option surgeons had for the last 25 years to provide stabilization when indicated, along with the decompression procedure,” said Hal Mathews, M.D., executive vice president and chief medical officer. “Importantly, Coflex was able to deliver better outcomes at a significantly lower cost to the healthcare system, which we believe is an important mandate of the current healthcare reform law.”