Trade Resources Industry Views Soft Tissue Regeneration Rotator Cuff Repair Device Is Cleared by FDA

Soft Tissue Regeneration Rotator Cuff Repair Device Is Cleared by FDA

The US Food and Drug Administration (FDA) has cleared Soft Tissue Regeneration's biodegradable scaffold for use in soft tissue augmentation and rotator cuff repair.

The STR GRAFT scaffold, a patch, can be draped over the tendon, that sits on the shoulder bone, for anchoring with sutures so that the tendon, bones and nearby tissues heal.

STR GRAFT , which is thinner about 1 millimeter, lessens pain, speeds recovery time and drastically reduces surgical failure rates, claims an early stage orthopedic device company.

Soft Tissue Regeneration founder Cato Laurencin said, "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."

The company is expecting to bring STR GRAFT on the market by 2014.

Source: http://orthopedicdevices.medicaldevices-business-review.com/news/fda-clears-soft-tissue-regeneration-rotator-cuff-repair-device-040113
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FDA Clears Soft Tissue Regeneration Rotator Cuff Repair Device