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