Stryker InSpace Balloon Implant
WHAT IS IT
- A FDA-cleared minimally invasive biodegradable subacromial balloon spacer
- Designed to restore the subacromial shoulder space after massive irreparable rotator cuff tears
- Alternative approach to invasive surgery that avoids the use of sutures or other types of fixation products
Who is it For?
- Patients 65 and older who would benefit from shorter surgical treatment
- Massive irreparable full thickness measuring > 5cm in diameter, involving at least two tendons
- Mild to moderate glenohumeral arthritis, no cartilage damage to shoulder
- Functional deltoid muscle
- No evidence of glenohumeral instability, or missing / nonintact coracoacromial ligament
- No neurovascular compromise, blood coagulation disorders, compromised immunity, severe chronic disease (i.e. heart failure, cirrhosis, chronic renal failure)
Product Details
- Comes in small medium and large size for anatomical compatibility
- Not made with any natural rubber latex, only biodegradable polymer
- Supplied sterile
- Used outside U.S. since 2010, cleared for use in U.S. in 2021
PROCEDURE AND OUTCOMES
- Operative time advantage (InSpace: 44 min, partial repair 71 min)
- Deployment takes an average of 4 minutes
- Balloon biodegrades over approximately one year
- Early return to range of motion maintained to 24 months
- Early improvement at 6 weeks