FDA approves new rotator cuff repair device
The FDA has granted clearance to Soft Tissue Regeneration to market its STR Graft, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.
According to a company press release, the STR Graft is a three-dimensional braided engineered matrix, similar to a patch, that can be draped over the tendon that sits on the shoulder bone, anchoring it with sutures to keep it in place during surgery while the tendon, bones and nearby tissues heal.
Expected to be on the market by 2014, the graft lessens pain, speeds recovery time and reduces surgical failure rates.