Startup solves the irreparable rotator cuff problem with balloon technology

OrthoSpaceBalloon for Irreparable Rotator Cuffs! (Orthopedics This Week)

see also…   50 Companies that are leading innovation in Sports Medicine

Balloon as spacer/re-educator…Joseph A. Abboud, M.D., an orthopedic surgeon at the Rothman Institute in Philadelphia, is helping patients who have suffered massive irreparable rotator cuff (RC) tears. Dr. Abboud tells OTW, “There are many patients with these types of tears who have been told that they cannot be helped arthroscopically. An FDA IDE [investigational device exemption] study is now underway in the U.S. at several centers, including The Rothman Institute in Philadelphia, Pennsylvania, to evaluate a new device called InSpace. This device, is manufactured by an Israeli company named OrthoSpace and has been approved and available in Europe for over five years with encouraging data reported.”

“With difficult RC tears you may not be able to bring the tissue of the rotator cuff back to the bone effectively thus impacting the healing cascade. One way to circumvent this problem is to use reverse shoulder arthroplasty (RSA); which is a fairly invasive procedure. The InSpace technology, which works in the subacromial space, involves inserting a saline-filled biodegradable balloon that is inflated to the precise amount needed for the shoulder in question. The procedure, unlike RSA, is done arthroscopically in 10-15 minutes.”

“The balloon sits between the humeral head and the acromion and helps to re-center the humeral head relative to the glenoid. The thought is that by helping to re-center the humeral head, you are redirecting some of the muscle forces across the joint. Therefore the net vector of forces around the joint are closer to what we have in the native normal joint than the decompensated chronic rotator cuff deficient shoulder. We also know that patients who have chronic progressive rotator cuff tears often develop the ability to compensate for their deficient rotator cuff without even being aware of this learned behavior. By inserting this biodegradable balloon we are providing the shoulder the opportunity to potentially learn this compensatory behavior in the hopes that the patient develops a chronic compensated and asymptomatic rotator cuff tear type shoulder. In essence we are not fixing the irreparable rotator cuff, rather we are re-educating the shoulder so that it learns to compensate better. Within three months the biodegradable material loses its ‘balloon’ state and is fully resorbed by twelve months.”

“The potential benefits of this type of procedure are substantial, including the ability to have it done arthroscopically with a short anesthesia time, reduction in pain and a potential for increase in function. And theoretically, depending on the study outcome, there is the potential in the future that if over time symptoms recur, we could repeat the procedure with few downsides. As with any FDA IDE study, we have to see what the final data analysis shows to be sure this will be an efficacious intervention for our patients in the future.”