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To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superion™ IDS device | Experimental | Superion™ Indirect Decompression System (IDS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superion™ IDS device | Device | The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of success at the 24-month follow-up visit | Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:
| 24-Months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction: VertiFlex® Patient Satisfaction Survey | Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale | 24-, 36-, 48- and 60-Months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Research Institute, LLC | Carlsbad | California | 92009 | United States | ||
| MarinHealth Spine Institute |
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| Larkspur |
| California |
| 94939 |
| United States |
| Vitamed Research | Rancho Mirage | California | 92270 | United States |
| IPM Medical Group Inc. | Walnut Creek | California | 94598 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| The Orthopaedic Institute | Gainesville | Florida | 32607 | United States |
| Alliance Spine and Pain Centers | Atlanta | Georgia | 30326 | United States |
| Centurion Spine and Pain | Waycross | Georgia | 31501 | United States |
| North Idaho Day Surgery | Post Falls | Idaho | 83854 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Ascension Alexian Brothers | Elk Grove Village | Illinois | 60007 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Neuroscience Research Center, LLC | Overland Park | Kansas | 66215 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Michigan Pain Specialists | Ypsilanti | Michigan | 48198 | United States |
| Weill Cornell Medical University | New York | New York | 10065 | United States |
| Pacific Sports and Spine, LLC | Eugene | Oregon | 97401 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17601 | United States |
| SC Pain and Spine Specialists | Murrells Inlet | South Carolina | 29576 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Swedish Health Services | Seattle | Washington | 98122 | United States |
| Northwest Pain Care | Spokane | Washington | 99201 | United States |
| The Spine and Nerve Center of Saint Francis Hospital | Charleston | West Virginia | 25301 | United States |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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