Elevating motion
InSpace is the industry’s only minimally invasive biodegradable, subacromial spacer for arthroscopic treatment of massive, irreparable rotator cuff tears (MIRCTs)*. It is designed to restore the subacromial space without requiring sutures or fixation devices.
InSpace presents a streamlined, arthroscopic procedural option that may result in sustained, clinically meaningful improvements in shoulder function and symptoms for your patients. (NCT02493660)
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Clinically proven results
- InSpace is the only FDA cleared MIRCT surgical solution supported by a level 1 randomized controlled trial that preserves musculoskeletal tissues and bone and does not require the use of anchor or permanent implant placement*.
- Clinical trial evidence demonstrating clinically meaningful improvements in shoulder function and symptoms at two years.
- High rate of clinical success, defined as meeting the study primary endpoint, in the InSpace study group at 24 months. (InSpace: 87.8%, Partial Repair: 88.1%)
- Early return to range of motion that is maintained out to 24 months.
- InSpace resulted in a significant advantage for operative time compared to partial repair. (InSpace: 44 min, Partial Repair: 71 min)
- Similar rates of Subsequent Secondary Surgical intervention (SSSI) through 24 months (InSpace: 4; Partial Repair 3).
- No InSpace devices required explanation.
- No subject experienced a Serious Adverse Device Effect (SADE) through the entire 24 months of study.
View Dr. Verma's InSpace surgical technique video
*The InSpace™ subacromial tissue spacer system is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
1000903848 Rev. A