InSpace Experience Fragment
InSpace Experience Fragment

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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The solution you’ve been waiting for. The InSpace implant helps fill an unmet clinical need, arming you with a solution for MIRCTs that requires a shorter procedural time and is less invasive than other surgical treatment options.

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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%)
Table 1: Primary composite endpoint - month 24

 

 

 

 

 

 

  • 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.

 

*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.

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