Rotation Medical gains FDA clearance for rotator cuff repair (VIDEO)

Rotation Medical pic 2Startup’s rotator-cuff fixer gets FDA approval (Video) (BizJournal Twin Cities)

Medical-device startup Rotation Medical Inc. has received regulatory approval to sell its technology for repairing small rotator-cuff tears.

The Plymouth-based company developed a collagen scaffold that is attached to shoulder tendons using a set of disposable instruments.

What’s unique about the product is there is evidence it can spark new tendon tissue growth, Rotation Medical President and CEO Martha Shadan told me in an interview.

Rotator-cuff disease is a common source of shoulder pain often treated with cortisone shots and physical therapy, Shadan said. Tears tend get worse over time, however. Rotation Medical is betting it can reduce that risk through new tissue growth.

The disposable nature of the company’s instruments will also offer an advantage because health providers would need to sterilize reusable instruments, Shadan said.

Rotation Medical was spun out of Plymouth med-tech incubator Denali Medical in  2009. It’s  raised about $20 million in venture capital from firms such as New Enterprise Associates.

Check out this video from Rotation Medical to get a sense of how the procedure works.

https://www.youtube.com/watch?v=kDS-DgNVTBg#t=15

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