Approval Order Statement
APPROVAL FOR THE SUPERION INTERSPINOUS SPACER (ISS). THIS DEVICE IS INDICATED TO TREAT SKELETALLY MATURE PATIENTS SUFFERING FROM PAIN, NUMBNESS, AND/OR CRAMPING IN THE LEGS (NEUROGENIC INTERMITTENT CLAUDICATION) SECONDARY TO A DIAGNOSIS OF MODERATE DEGENERATIVE LUMBAR SPINAL STENOSIS, WITH OR WITHOUT GRADE 1 SPONDYLOLISTHESIS, CONFIRMED BY X-RAY, MRI AND/OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS, AND/OR CENTRAL CANAL OR FORAMINAL NARROWING. THE SUPERION® ISS IS INDICATED FOR THOSE PATIENTS WITH IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, NUMBNESS, AND/OR CRAMPING, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTHS OF NON-OPERATIVE TREATMENT. THE SUPERION® ISS MAY BE IMPLANTED AT ONE OR TWO ADJACENT LUMBAR LEVELS IN PATIENTS IN WHOM TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS, FROM L1 TO L5. FOR THIS INTENDED USE, MODERATE DEGENERATIVE LUMBAR SPINAL STENOSIS WAS DEFINED AS FOLLOWS:1) 25% TO 50% REDUCTION IN THE CENTRAL CANAL AND/OR NERVE ROOT CANAL (SUBARTICULAR, NEUROFORAMINAL) COMPARED TO THE ADJACENT LEVELS ON RADIOGRAPHIC STUDIES, WITH RADIOGRAPHIC CONFIRMATION OF ANY ONE OF THE FOLLOWING:A) EVIDENCE OF THECAL SAC AND/OR CAUDA EQUINA COMPRESSION;B) EVIDENCE OF NERVE ROOT IMPINGEMENT (DISPLACEMENT OR COMPRESSION) BY EITHER OSSEOUS OR NON-OSSEOUS ELEMENTS; ANDC) EVIDENCE OF HYPERTROPHIC FACETS WITH CANAL ENCROACHMENT. 2) AND ASSOCIATED WITH THE FOLLOWING CLINICAL SIGNS:A) PRESENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION (PF) DEFINED AS A SCORE OF >= 2.0 OF THE ZURICH CLAUDICATION QUESTIONNAIRE (ZCQ); ANDB) ABILITY TO SIT FOR 50 MINUTES WITHOUT PAIN AND TO WALK 50 FEET OR MORE. |
