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Newly FDA-Approved Balloon Spacer Offers Alternative to Painful Rotator Cuff Surgery – Rustwire

At age 69, Cathi Mintautas still golfs, despite having torn both her rotator cuffs. She underwent surgeries to repair the tendons, which involve lengthy and painful recoveries.

“You sleep six weeks in the chair. They’re very painful,” Mintautas said.

When Mintautas tore her left rotator cuff for the second time in 2017, she went to see Dr. Nik Verma at Midwest Orthopaedics at Rush. Dr. Verma was conducting a clinical trial at the time, involving a balloon spacer made by medical device company Stryker.

“It’s a very small balloon that goes into the shoulder joint itself,” Dr. Verma said, describing the device.

Instead of repairing the tendon, a surgeon injects the balloon into the shoulder joint and then fills it with saline. The balloon spacer then stops the top and bottom shoulder bones from rubbing together, causing pain.

“What we’re trying to do with a device like this is to allow the other muscles to take over, to allow the shoulder to develop a well-compensated state, so even though they don’t have a shoulder that’s working, the shoulder is good enough to allow them to be functional,” Dr. Verma said.

The InSpace biodegradable implantable balloon is about the size of a compressed ping pong ball filled with saline. It disintegrates and is absorbed by the body within 12 months.

Approved in Europe for years, the FDA approved use of the the balloon spacer for Americans over the age of 65 in July. That’s about 10 percent of Dr. Verma’s rotator cuff patients.

“For younger patients we try to repair the tendon, but as we get older, results drop off,” Dr. Verma said.

The recovery is significantly quicker after a balloon spacer injection.

“These patients are out of a sling within two weeks, generally doing activities in four weeks, done with rehab in about 12 weeks,” said Dr. Verma.

Four years after Mintautas’ balloon spacer injections, she’s still swinging her way through retirement on the golf course, glad she was part of the clinical trial.

“Absolutely, I’m living proof, you know?” Mintautas said.

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