At the 12th Annual Spine, Orthopedic and Pain Management Driven ASC Conference in Chicago on June 12, Hallett Mathews, MD, executive vice president and CMO for Paradigm Spine, discussed motion preserving MIS stabilization for stenosis surgery in ambulatory surgery centers.
Dr. Mathews said the ability to decompress in an outpatient center, stabilize the patient and then perform a lumbar spinal stenosis — all in an ASC setting — is relatively novel.
"As technology, technique and evidence come together, we have the ability to have that discussion," he said. "Can patients undergo stabilization in an ASC setting? The answer is 'sure'" said Dr. Hallett. But for patients to undergo surgical decompression and stabilization as an outpatient procedure, the only FDA-approved and ASC-compatible device for this is coflex, an interlaminar stabilization device.
The coflex device is indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients who have at least moderate impairment in function, experience symptoms of leg, buttocks or groin pain, with or without back pain, and who have undergone at least six months of nonoperative treatment.
Dr. Mathews referred to a spine surgeon who has used the coflex device, and he described the patient and her outcomes. The 72-year-old patient had pseudoclaudication and had undergone multiple pain management procedures. Still, she continued to have debilitating pain into the buttocks and legs.
The surgeon stabilized her with the coflex device and described the outcomes as some of the more impressive he's seen. When the stabilization with coflex is done in the outpatient surgery center, the patient can go home in two hours. The surgeon also said that for people in the ASC setting, the coflex is not more of an investment in equipment than a microdiscectomy.
Dr. Mathews cited results from a clinical trial that compared outcomes of coflex patients to those of patients who received spinal fusions. At six weeks after surgery, 77 percent of coflex patients had early improvement in physical function, compared to 67 percent of fusion patients. Also, at six weeks after surgery, 85 percent of coflex patients had early improvement in pain and function, compared to 68 percent of fusion patients.
"Prior to this, only stenosis without stabilization could be done [in ASCs]. The value will be driven in disease management in the ASC setting versus the inpatient setting," said Dr. Mathews. "This is one of the few technologies that touches all stakeholders."
There are also economic advantages to using the coflex device. 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. The study 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.
A 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."
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