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Medical startup receives FDA clearance

December 13, 2019
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A medical device startup in the region has received FDA clearance for a new product.

Holland-based Shoulder Innovations received the approval for its InSet Plus augmented glenoids — the indented portion of the shoulder’s ball joint — for its InSet Total Shoulder System, according to the company this week.

The InSet Total Shoulder System is used to treat significant disability in degenerative, rheumatoid and traumatic disease of the shoulder joint, as well as death of bone tissue in the shoulder joint due to lack of blood flow.

Shoulder Innovations said the existing InSet product has allowed surgeons to place the artificial bone pocket into the bone, creating more secure fixation than traditional methods. The new InSet Plus product is designed to allow surgeons to create optimal pocket depths in more eroded bones, creating stronger stability.

“Surgeons are seeking implant systems that can help to reduce implant loosening and revision rates — therefore increasing patient satisfaction and reducing overall healthcare costs,” said David Blue, chief commercialization officer, Shoulder Innovations.

In the U.S., there are more than 100,000 total shoulder patients operated on annually, with demand for the procedure growing at about 10% per year, according to Shoulder Innovations.

Results published in the Journal of Shoulder and Elbow Surgery show improved implant stability with the InSet Total Shoulder System, Shoulder Innovations said. Additional results published in JSES show there were no complications, no cases of implant loosening and no revision surgeries performed in the series after an average 8.7-year follow-up.

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