Soft Tissue Regeneration, an orthopedic technology company based in New Haven, Connecticut, received clearance from the United States Food and Drug Administration for its rotator cuff repair device. According to a press release by the company, the new tissue engineering system can be used to regeneratate damaged tendons and ligaments.
The FDA clearance allows Soft Tissue Regeneration to market its STR Graft rotator cuff repair device. The STR Graft uses a specialized biodegradable scaffold for soft tissue augmentation. During an operation, surgeons can place the biodegradable scaffold over a shoulder bone tendon. This scaffold can be used in conjunction with sutures to hold the tendon in place while nearby tissues naturally heal.
Unlike other products on the market, the STR Graft comprises an engineered three-dimensional braided matrix. Other similar products on the market are made of cadaver or animal tissue and usually offer inferior strength. In addition, these products can often cause sutures to pull. With the STR Graft, a stronger build material provides a thinner, high-durability biodegradable scaffold that reduces pain and improves recovery time.
Dr. Cato Laurencin is the founder of Soft Tissue Regeneration Inc. In prepared remarks, he 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."