FDA OK's Stryker's Implantable, Biodegradable Balloon Spacer For Shoulder Injury

More than a decade after receiving European CE mark approval, an implantable balloon spacer, InSpace, recently acquired by Stryker Corp SYK, will make its U.S. debut after FDA approval.
The InSpace device is placed in the subacromial space of the shoulder to help heal a torn rotator cuff.
It steps in for the fluid-filled bursa, the natural cushion in the shoulder that typically becomes inflamed and painful when the rotator cuff's tendon tears create space between the shoulder and arm's scapula acromion and humerus bones.
The balloon implant biodegrades over about six to 12 months and, during that time, reduces friction between the bones to lessen pain and improve recovery after a shoulder injury.
The device is specifically indicated for patients 65 years and older suffering from trauma or osteoarthritis-related degradation.
The FDA nod comes nearly 11 years after the InSpace device was cleared for use in Europe.
Stryker acquired the device's maker, OrthoSpace, in 2019 via a deal valued at up to $220 million.
Price Action: SYK shares are down 1.02% at $262.22 during the market session on the last check Tuesday.

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