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Delivering the SAFETY and EFFICACY you require backed by the Level 1 EVIDENCE you demand 1-3 so that patients can live their healthiest lives. SEE the Difference with i-FACTOR ® INTRODUCING PearlMatrix with P-15 Peptide is the first and only bone growth accelerator proven to accelerate fusion in the lumbar spine. PearlMatrix demonstrated over 2x more patients fused at 6-months in a Level 1, PMA, IDE study with 60% high-risk patients vs. local autograft. *†1,2 Fusion takes time. ACCELERATE IT. Visit our website to learn more about PearlMatrix at: www.PearlMatrix.com PearlMatrix demonstrated statistically superior fusion speed at 24 months with over 2x more patients fused at 6 months. *1 PearlMatrix TM Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. PearlMatrix is intended to be used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment. PearlMatrix is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolis- thesis. DDD is defined as back and/or radicular pain of discogenic origin with degeneration of the disc confirmed by history, physical exam, and radiographic studies. PearlMatrix should not be used in situations where there is an absence of load-bearing structural support at the graft site, sensitivity to components or the product, active infection at the operative site, or operative site subject to excessive impact or stress. Care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure such as individuals with bleeding disorders of any etiology, long-term steroidal therapy, immunosuppressive therapy or high dosage radiation therapy. The effect of PearlMatrix on pregnant or nursing patients has not been evaluated. PearlMatrix in a TLIF procedure was associated with a higher rate of secondary surgical interventions compared to local autograft. PearlMatrix should only be used by physicians who are experienced with TLIF procedure and in surgical procedures where it can be adequately contained at the bony void or defect. To learn more about PearlMatrix, its indications, contraindications, warnings, precautions and potential adverse events, visit our website at www.Cerapedics.com or refer to the PearlMatrix Instructions for Use for complete safety and risk information. *Demonstrated statistically superior time-to-fusion in a single-level TLIF PMA IDE study vs. local autograft. † High-risk includes nicotine use, BMI ≥ 30 and/or Type 2 diabetes. 1. PearlMatrix Instructions For Use. Cerapedics. 2. Internal Data on File as of 9/9/24. ML-1600