Postmarket Registry for Evaluation of the Superion® Spacer (PRESS)

Boston Scientific

Status: Completed

Conditions: Lumbar Spinal Stenosis

Treatments: Device: Superion® Indirect Decompression System (IDS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04087811

16-VISS-01

Details and patient eligibility

About

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).

Full description

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

Enrollment: 1,674 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female patients ≥45 years of age
• symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
• meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)

Exclusion criteria

• not contraindicated as described in the labeled indications for use

Trial design

1,674 participants in 1 patient group

Superion® Indirect Decompression System (IDS)

Description:

Superion® Indirect Decompression System (IDS) - Interspinous Spacer

Treatment:

Device: Superion® Indirect Decompression System (IDS)