A decade after EU debut, Stryker's balloon implant for shoulder tears lands stateside with FDA nod

More than a decade after nabbing CE mark approval to be sold in Europe, an implantable balloon spacer recently acquired by Stryker will make its U.S. debut.

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—to create space between the shoulder and arm’s scapula, acromion and humerus bones.

The balloon implant biodegrades over the course of about six to 12 months, and, in that time, reduces friction between the bones to lessen pain and improve recovery after a shoulder injury.

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With its new FDA clearance, the InSpace system will now be available to U.S. patients with massive, irreparable rotator cuff tears, where the tendon has torn and retracted, and cannot be directly reconnected to the head of the upper arm's humerus bone.

The device is specifically indicated for patients 65 years and older suffering from trauma or osteoarthritis-related degradation, as they would likely be better served by the minimally invasive implantation and its relatively short healing period than a full operation for partial rotator cuff repair.

“Current strategies treating massive irreparable rotator cuff tears often present a challenge to surgeons and may require long and frustrating rehabilitation processes for patients,” said Nikhil Verma, M.D., lead investigator in the clinical study that helped lead to InSpace’s FDA clearance.

The biodegradable implant, meanwhile, is a “game-changer,” Verma said, which “presents a shorter, less invasive option that may enable sustained, clinically meaningful improvements in shoulder function and symptoms.”

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The FDA OK comes nearly 11 years after the InSpace device was cleared for use in Europe. In that time, more than 29,000 of the balloon spacers have been implanted, according to the company. But Stryker has only been the owner of the InSpace system for a handful of those years: It acquired the device’s maker, OrthoSpace, in 2019 via a deal valued at up to $220 million.

The acquisition was completed while the long-term North American study of the system was still underway. That study, which wrapped up in early 2020, found that nearly 88% of patients implanted with the InSpace balloon met the primary endpoints of reduced pain and improved range of motion two years after the implantation.

That’s slightly below the 88.1% success rate of partial rotator cuff repair surgery, but the study found that patients using InSpace experienced a better and sustained range of motion than those who underwent a partial repair.