Study shows 44.1% Device Specific Complications with Vertiflex Superion

Dr. Fabio Pencle, MBA; Dr. Jason Seale, MBA

The study shows 44.1% Device Specific Complications with Vertiflex Superion plus 21.1% spinous process fractures.

The purpose of this study was to compare the short-term complications of the Vertiflex Superion interspinous spacer (SISS) with laminectomy or laminotomy and highlight device-specific long-term outcomes with SISS.

The study evaluated 189 SISS patients compared with 378 matched controls who underwent primary lumbar spine laminectomy or laminotomy.  Results showed a total of 44.4% of patients in the SISS group experienced device-specific complications with 11.1% of patients experiencing device malfunction. A total of 21.1% experienced a spinous process fracture with 20.1% requiring device explantation, and 24.3% requiring subsequent spine surgery. The article concluded that Vertiflex Superion patients will likely need additional procedures with substantial cost to the healthcare system. [1]

  1. Welton L, Krieg B, Trivedi D, et al. Comparison of Adverse Outcomes Following Placement of Superion Interspinous Spacer Device Versus Laminectomy and Laminotomy. Int J Spine Surg. 2021;15(1):153-160. doi:10.14444/8020 https://pubmed.ncbi.nlm.nih.gov/33900969/

Dr. Fabio J. Pencle is a medical doctorpreneur and Associate Professor. He holds a master’s in business administration.

Dr. Jason A. Seale is a medical doctorpreneur. He holds a master’s in business administration degree.

Dr. Fabio Pencle, MBA