Becker's Spine Review

14 SPINE DEVICE & INNOVATION Long-Term Efficiency of Paradigm Spine's coflex By Megan Wood P aradigm Spine, a New York- based developer of lumbar spinal stenosis treatment solu- tions, published "Evaluation of Decom- pression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial." Michael Musacchio, MD, authored the piece, and International Journal of Spine Surgery published it. Here are four observations: 1. e data reveals the long-term sus- tained therapeutic effect of coflex Inter- laminar Stabilization for lumbar spinal stenosis patients compared to fusion. 2. ILS aer decompression resulted in outcomes similar or superior to fusion with pedicle screws. 3. One- and two-level procedures demonstrated similar results to fusion, and two-level D+ILS procedures demonstrated a decreased rate of revi- sion compared to fusion procedures. 4. Hallett Mathews, MD, MBA, executive vice president and chief medical officer of Paradigm Spine, said fusion stabilization should not be the only option for spinal stenosis patients. "e results of this study with five-year follow-up support that decompression and ILS is an effective and sustainable treatment option for moderate to severe spinal stenosis and not an inevitable precursor to fusion," the study authors concluded. n Orthobiologics in Spinal Fusion: 5 Key Notes on Outcomes for Cerapedics' i-FACTOR By Laura Dyrda O rthobiologics company Cera- pedics reported results from the FDA investigational device ex- emption clinical trial for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures, pub- lished in Spine. Here are five key notes on the random- ized, single-blinded study where patients received either autograft or i-FACTOR: 1. There were 154 patients who under- went the procedure with bone graft and autograft and 165 with i-FACTOR bone graft. The i-FACTOR bone graft reported 88.9 percent fusion rate, compared with the control group with 85.8 percent fusion rate. 2. There was high neurological success rate for i-FACTOR and the control group — 93 percent. 3. There wasn't any difference in the ad- verse event rates for both groups. 4. The overall success rate for the four primary outcomes showed 69 percent success factor for the i-FACTOR bone graft, compared with 57 percent in the autograft group. The difference was statis- tically significant for superiority. 5. The i-FACTOR bone graft is based on synthetic small peptide technology and sports bone growth through cell attach- ment and activation. The technology has FDA approval for use in ACDF procedures for patients with degenerative cervical disc disease. "Until now, alternatives to autograft bone for use in ACDF procedures had not been evaluated in rigorous randomized, controlled studies," said co-investigator and lead author of the Spine paper Paul M. Arnold, MD, professor of neurosurgery at University of Kansas Medical Center. "This study demonstrates that treatment with i-FACTOR bone graft results in similar and on some metrics superior outcomes compared to local autograft bone." n LDR's Mobi-C vs ACDF: 5 Year Costs & Outcomes By Anuja Vaidya N eurosurgery has published a peer-reviewed article regarding the cost-effective- ness of LDR's Mobi-C Cervical Disc. Here are three takeaways: The article examined the cost-effec- tiveness of two-level cervical total disc replacement with the Mobi-C Cervical Disc as compared to ante- rior cervical discectomy and fusion based on five-year outcomes data. The study found that for patients with two-level degenerative disc disease, TDR with Mobi-C seems to be a "highly cost-effective surgical modality compared with ACDF." Mobi-C is a cobalt chromium alloy and polyethylene mobile-bear- ing device that is designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. "We are excited to have this very im- portant, long-term economic analy- sis of Mobi-C published, especially in such a prestigious journal as Neu- rosurgery. The principal finding of this study, that two-level Mobi-C appears to offer improved cost-ef- fectiveness compared to ACDF (based on the 60-month outcomes), represents further evidence to support broader payer coverage for two-level cervical disc replacement and greater surgeon adoption of Mobi-C," said Christophe Lavigne, president and CEO of LDR. n

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