5 Key Cost & Quality Findings on Spinal Fusion vs. coflex

Spinal Tech

Two recently-published clinical journal articles examine the cost-effectiveness and safety of performing lumbar spine surgery with fusion as well as Paradigm Spine's coflex Interlaminar Stabilization device on an outpatient basis for spinal stenosis patients.

The articles have significant findings that could make a huge impact on the clinical and economic outcomes of spinal intervention. Here are five key findings from the studies:


1. The coflex device and procedure is better from a comparative effectiveness perspective for treating lumbar spinal stenosis when compared with instrumented fusion. An article published in the March 2014 edition of the Journal of Clinicoeconomics and Outcomes Research found savings over five years of $11,700 for the coflex procedure. The average Medicare payments over five years for coflex were $15,182, compared with $26,863 for fusion patients.


2. The initial study on comparative cost effectiveness also found the coflex device derived more utility than patients treated with fusion, on average, but at a lower cost. The cost advantage was even larger when examining commercial insurance payments as well as when coflex was used for two-level procedures as compared to one-level procedures.


3. The second study published in the Journal of Neurosurgery: Spine examined how fusion after spinal decompression impacted elderly patients. The researchers found one in four patients underwent reoperations within two years and nearly half were readmitted for a surgery-related complication, corresponding to overall Medicare costs of $103 million two years after surgery.


"Both publications highlight the common use of spinal fusion after decompression of spinal stenosis, and unfortunately, display the high costs and revision rates associated with spinal fusion in the older age group," said Paradigm Spine Chairman and CEO Marc R. Viscogliosi in a news release. "We are pleased to see the coflex Interlaminar Stabilization procedure is being performed more cost-effectively and with significant cost savings compared to spinal fusion in the Medicare age group."


4. As more literature on the safety and effectiveness of coflex are released, the company has grown. In February, Paradigm Spine entered into a credit agreement with PDL BioPharma to provide up to $25 million of secured debt financing. Armentum Partners acted as financial advisors to the transaction.


The initial $50 million was provided at the transaction's close and the remaining $25 million will be funded in two equal trenches when specific milestones are achieved. "Following a year of record growth, Paradigm Spine is well positioned for its next phase of expansion. Given our coflex FDA approval, this financing assists us in accelerating Paradigm's market penetration, especially domestically," said Mr. Viscogliosi.


5. Payers are also seeing the benefit of coflex for spinal stenosis treatment. In January 2013, Cahaba Government Benefit Administrators gave Paradigm Spine a favorable Medicare determination for coflex to use in Alabama, Georgia and Tennessee. The device received FDA premarket approval in 2012.


More Articles on Spine Devices:
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Behind the K2M IPO: CEO Eric Major Talks Strategy, Innovation & Future Financial Growth
15 Spine Devices Receive FDA 510(k) Clearance in May

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