Postmarket Outcomes Study for Evaluation of the Superion™ Spacer (PRESS2)

Boston Scientific

Status: Completed

Conditions: Lumbar Spinal Stenosis

Treatments: Device: Superion™ IDS

Study type: Observational

Funder types: Industry

Identifiers

NCT04563793

A4086

Details and patient eligibility

About

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Full description

The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Enrollment: 129 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
• Signed a valid, IRB approved informed consent form

Key Exclusion Criteria:

• Meets any contraindication in BSC Indirect Decompression Systems local IFU

Trial design

129 participants in 1 patient group

Superion™ IDS

Description:

All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.

Treatment:

Device: Superion™ IDS