The FDA clears Soft Tissue Regeneration’s Str graft, a device used for soft tissue augmentation and rotator cuff repair.
Soft Tissue Regeneration, an early stage orthopedic device maker, has received FDA clearance for its Str graft, a biodegradable scaffold that can lessen patient’s pain and reduce surgical failure rates following rotator cuff surgery.
The Str graft, a 3-dimensional braided “patch,” is about 1 millimeter. Surgeons using the device drape it over the tendon with sutures to help the tendon, bones and nearby tissues heal.
“There are several products available to augment rotator cuff repair, but they suffer from strength, suture pull-through and surgical deployment issues, all of which the Str graft addresses,” founder and the device developer Dr. Cato Laurencin said in prepared remarks.
Nearly 2 million people suffered rotator cuff problem in 2008, according to the American Academy of Orthopaedic Surgeons.
Compared with the traditional devices,which are made of cadaver or animal tissue, the Str graft prevents sutures to pulling, while reducing the pain of the patients and improving the surgical outcomes, according to the press release.
The newly approved device Str graft is expected to be on the market by 2014, the company said.